Abstract
Context
Patellofemoral pain syndrome (PFPS) is one of the most common determinants of knee pain. The causes of PFPS are multifactorial, and most treatment approaches are conservative. There are many kinds of therapy for this syndrome, which are based on building strength, flexibility, proprioception, and endurance. Training is functional and progression is gradual. Our hypothesis is that total-body osteopathic manipulative therapy (OMTh; manipulative care provided by foreign-trained osteopaths) focused on the management of somatic dysfunctions could be useful for managing the pain of patients with PFPS.
Objective
To investigate the effect of OMTh on pain reduction in patients with PFPS.
Methods
This pilot study was randomized, controlled, and single-blinded with 2 months of follow-up. Qualified participants were randomly assigned to 1 of 2 groups: OMTh group or placebo group. Each participant received either 4 sessions of OMTh or 4 sessions of manual placebo intervention that consisted of passive touching without joint mobilization in a protocolled order. A visual analogue scale (VAS) was used to assess general knee pain, peripatellar pain, pain after prolonged sitting, pain during the patellar compression test, and pain during stair ascent and descent. Pain assessment was performed before the baseline (T0), second (T1), third (T2), and fourth (T3) sessions, and follow-up (T4) was performed 8 weeks after T3.
Results
Thirty-five participants were enrolled the study. The VAS score was significantly reduced and clinically relevant in the OMTh group after each treatment and after 2 months of follow-up. The change in the VAS score before each treatment indicates that the most improved areas at T1 compared with T0 were lumbar and sacral with improvements in 83% and 40% of patients, respectively. At T2 compared with T1, the most improved areas were cervical and sacral with improvements found in 58% and 36% of patients, respectively. The number of dysfunctions that were diagnosed decreased during the baseline to T3 period (40% change). The correlation analysis showed significant results for the dysfunction and the compression test at T2 (P=.01, ρ=0.543).
Conclusion
Significant differences in VAS scores were found between the OMTh and placebo groups. These findings underline how OMTh can lead to reduced pain in patients with PFPS.
Patellofemoral pain syndrome (PFPS) is one of the most common causes of knee pain and affects both athletes and people who are sedentary.1 The syndrome has a greater predisposition in women and adolescents who have had no structural changes or significant pathologic changes in the articular cartilage.2 Pain occurs during at least 2 of these activities: going up or down stairs, running, jumping, holding a seated position, squatting, or resting on the knees for a period of time.3,4 Symptoms are usually due to parapatellar or retropatellar tissues with crackles, stiffness, swelling, and functional deficits. Ninety percent of patients with PFPS still had symptoms 4 years after diagnosis, and only 6% were symptom free at a 16-year follow-up.5-7 The causes of PFPS are multifactorial and include hypotrophy of the vast medial muscle or an alteration of the muscular balance of the lower limb, anatomical changes, overuse of the lateral structures, and inappropriate physical activities with increased foot pronation, internal rotation of the tibia, and valgus stress.8,9 Therefore, PFPS is often known as a diagnosis of exclusion10 and determined by physical tests. For example, the Clarke compression test is often used to diagnose PFPS; however, the sensitivity and specificity of physical tests are open to question.11
Most management approaches for PFPS are conservative, and surgical interventions are rare.12 Management programs may focus on improving strength, flexibility, proprioception, endurance, functional training, and gradual progression.13 A multimodal, nonoperative therapy with short-term use of nonsteroidal anti-inflammatory drugs, medially directed tape, and complex exercise programs that include the core, lower extremity, hip, and trunk muscles have been shown to be useful for managing PFPS. A consensus statement14 on exercise therapy and physical interventions to treat patients with PFPS was reached in 2017, which recommended a multidisciplinary approach focused on the musculoskeletal system, including manual therapy.15 Previous studies16,17 have supported the use of manipulative therapy, including the use of osteopathic techniques, such as osteopathic manipulative therapy18 (OMTh; manipulative treatment provided by a foreign-trained osteopath) combined with multimodal or exercise therapy for patients with PFPS.
The efficacy of OMTh has been reported in several clinical conditions such as primary headache,19,20 chronic lower back pain,21 chronic disease of the knee,22 and postsurgical management.23 The main advantage for patients is the effective relief of acute and chronic pain.24 We hypothesized that if OMTh is focused on the management of somatic dysfunctions, it could be useful for managing the pain of PFPS patients. Thus, the aim of this study was to assess the effect of OMTh in patients with PFPS.
Methods
Participants were recruited via a single email invitation from a database of the Centre Pour l'Etude, la Recherche et la Diffusion Osteopathiques clinic in Rome. Previously, the patients had been voluntarily recorded in the database after reading an advertisement for the clinic. The invitation explained that participation was voluntary, without incentives for participants, and dependent on the inclusion and exclusion criteria. All interested participants received information about the project by telephone interviews. An osteopath (V.M.) who was not involved in the intervention sessions assessed the eligibility of participants based on the inclusion and exclusion criteria.
Forty participants between 18 and 60 years of age who had a medical diagnosis of PFPS were recruited. Patellofemoral pain syndrome was diagnosed if the participants had a complaint of retropatellar or anterior knee pain that was provoked by 2 or more of the following activities: prolonged sitting, stair ascent, stair descent, squatting, kneeling, or isometric quadriceps contraction. The diagnosis was supported by magnetic resonance imaging (MRI) findings. Individuals were excluded if they had a history of prior knee surgery, any competing knee injuries (meniscal tears, patellar tendinopathy, ligamentous sprains, osteoarthritis, patellar bursitis), any cause of possible referred pain to the knee (eg, hip osteoarthritis), any systemic disease or connective tissue disorders or signs of lumbosacral nerve root compression, and if they had received prior OMTh. Interventions were performed at 2 osteopathic outpatient clinical centers from March 2016 to July 2018. Participants were enrolled randomly in 2 groups on the basis of consecutive sampling: the OMTh group that received manual treatment and the placebo group that received passive touching. Participants were unaware of the study design and outcomes and of group allocation. A researcher (M.T.) who was not involved in the intervention sessions carried out the randomization.
Study Design
This was a randomized, controlled, single-blinded pilot study with 2 months of follow-up. Treatment was given over an 8-week period. Each session was 45 minutes long, and each participant underwent 4 sessions of either OMTh or placebo manual treatment. Pain assessment was performed before the first (T0), second (T1), third (T2), and fourth (T3) sessions.
Follow-up (T4) was performed 8 weeks after T3. Approval of the study protocol was obtained from the institutional review board of Centre Pour l'Etude, la Recherche et la Diffusion Osteopathiques in Rome. The study was carried out in accordance with the Declaration of Helsinki and met the Good Clinical Practice standards. Informed consent was obtained from all participants before they were enrolled.
Intervention
The OMTh session was performed by 3 different osteopaths (S.P., C.M., F.M.), who had completed a training program in osteopathy associated with the Italian Core Competence in osteopathy25 and the European Standard on Osteopathic Healthcare Provision.26 During patient encounters, investigators collected data from the osteopathic structural examinations and applied diagnostic coding using the standardized Outpatient Osteopathic Subjective, Objective, Assessment, Plan Note Form table, which is a modified form of the Outpatient Osteopathic Assessment and Plan Form (2002 edition).27 This table was used to collect data for the evaluation of the 10 anatomical regions described in the International Classification of Diseases and Related Health Problems, Tenth Revision28: head, cervical, thoracic, lumbar, sacral, pelvic, lower extremities (left and right), upper extremities (left and right), ribs, abdomen, and other regions (eg, diaphragmatic region, pelvic floor region, lumbar/abdominal lateral wall region).29 For each of the patient's anatomical regions, the investigator diagnosed and graded the somatic dysfunction present based on tissue texture abnormality, asymmetry, restriction of motion, and tenderness, commonly referred to as TART.30 The OMTh techniques were focused on correcting the dysfunctions found during the initial physical examination. They included articular and myofascial techniques, balanced ligamentous tension, visceral manipulations, and osteopathy in the cranial field.28
The manual placebo treatment performed by the same osteopaths consisted of passive touching without joint mobilization in a protocolled order.31 First, the osteopath stood next to the bed with the patient in a prone position and touched the patient's lumbar spine for 10 minutes and dorsal spine for 10 minutes. Next, the patient moved to a supine position and the osteopath touched the patient's shoulders for 10 minutes, hips for 10 minutes, and neck, sternum, and chest for 5 minutes. The osteopaths were specifically trained to use the placebo protocol for passive touching by another researcher (M.T.). Participants were asked to avoid the use of drugs and other therapy during the study, although when they needed, they could use analgesics, muscle relaxants, and nonsteroidal anti-inflammatory drugs under medical supervision.32
Outcome Measures
A visual analogue scale (VAS) was used to assess general knee pain, peripatellar pain, pain after prolonged sitting, pain during the patellar compression test, pain during stair ascent, and pain during stair descent.
Statistical Analysis
Data distributions were analyzed using the Kolmogorov-Smirnov test and considered significant at P>.05. All results with a normal distribution were analyzed by means of a 2-way analysis of variance (ANOVA) test for repeated measures with the variables time and group for each VAS, with the time × group interaction significant at P<.05. A correlation analysis was performed between the change in each VAS score and the dysfunctions diagnosed. Another correlation analysis was performed for only the OMTh group that considered T0 as baseline, calculating the difference of the scores for the pain variables and the dysfunction for each time point (eg, T0-T1, T0-T2). For both correlation analyses, the correlation with P<.05 was considered significant. For each OMTh patient, we also calculated the reduction in dysfunction after each treatment by considering T0 vs T1, T1 vs T2, and T2 vs T3. We calculated the percentage between improvement and treatment by considering the highest ratio for the most treated areas. The number of dysfunctions diagnosed and the number of dysfunctions treated were reported.
Results
Statistical analysis was performed using the data of 35 patients who completed all evaluations (OMTh group, 20; placebo group, 15). Five patients were released before the end of the training for reasons not related to the trials. Demographic and clinical characteristics are reported in Table 1.
Demographic and Clinical Characteristics of Patients With Patellofemoral Pain Syndrome
| Patient Groups | Total, n | Age, y, Mean (SD) | Women, n | Right Side of PFPS, n | Duration of Symptoms, Mean (SD) |
|---|---|---|---|---|---|
| OMTh | 20 | 33.5 (13.8) | 9 | 10 | 20.1 (9.5) |
| Placebo | 15 | 32.2 (8.9) | 6 | 7 | 15.7 (7.5) |
Abbreviations: OMTh, osteopathic manipulative therapy (manipulative care provided by foreign-trained osteopaths); PFPS, patellofemoral pain syndrome.
The Kolmogorov-Smirnov test showed normal distributions for each VAS (P>.05). The OMTh group and placebo group were homogeneous at the baseline for each category of pain and for the dysfunction, as shown by the Kolmogorov-Smirnov test (P>.05). A 2-way ANOVA test showed the interaction between time and group for each VAS (P<.001). Significant results emerged for the single variables time and group. All results are reported in Table 2.
Visual Analogue Scale Score of Patients With Patellofemoral Pain Syndromea
| Visual Analogue Scale Score | Group Factora | Timea | Time × Groupb |
|---|---|---|---|
| General pain | F1,170=202.590 (P<.001) | F4,170=20.437 (P<.001) | F4,170=25.634 (P<.001) |
| Peripatellar pain | F1,136=129.412 (P<.001) | F3,136=12.263 (P<.001) | F3,136=7.125 (P<.001) |
| Prolonged sitting | F1,168=78.292 (P<.001) | F4,168=8.321 (P<.001) | F4,168=7.617 (P<.001) |
| Compression test | F1,170=209.985 (P<.001) | F4,170=11.704 (P<.001) | F4,170=15.285 (P<.001) |
| Ascending stairs | F1,170=146.017 (P<.001) | F4,170=3.383 (P=.011) | F4,170=8.134 (P<.001) |
| Descending stairs | F1,170=69.682 (P<.001) | F4,170=7.136 (P<.001) | F4,170=7.822 (P<.001) |
a 2-way analysis of variance for repeated measures with variables time and group for each visual analogue scale.
b Significant at P≤.05
Regarding the OMTh group, the correlation analysis showed significant results at T1 for peripatellar pain (P=.172, ρ=0.309) and descending stairs (P=.118, ρ=0.350). The percent change in the VAS score before each treatment indicates that the most improved areas at T1 compared with T0 were lumbar and sacral with improvements found in 83% and 40% of the patients, respectively. At T2 compared with T1, the most improved areas were cervical and sacral, with improvements found in 58% and 36% of patients, respectively. The VAS scores for each assessment are reported in Table 3.
Mean (SD) Group Visual Analogue Scale Scores for Pain at Each Assessment for Patients With Patellofemoral Pain Syndromea
| Assessment | ||||||
|---|---|---|---|---|---|---|
| Type of Pain | T0 | T1 | T2 | T3 | T4 | |
| General | ||||||
| OMTh | 6.57 (1.57) | 4.38 (2.01) | 2.67 (1.96) | 1.43 (1.60) | 0.95 (1.12) | |
| Placebo | 6.47 (1.19) | 6.27 (0.88) | 6.20 (1.01) | 6.33 (0.82) | 6.67 (0.82) | |
| Peripatellar | ||||||
| OMTh | 6.76 (2.02) | 4.52 (2.09) | 2.57 (1.89) | 1.48 (1.54) | 0.71 (0.85) | |
| Placebo | 6.80 (2.11) | 5.67 (1.35) | 5.53 (0.99) | 5.07 (1.67) | 5.27 (1.83) | |
| Prolonged Sitting | ||||||
| OMTh | 4.57 (2.80) | 2.05 (2.44) | 1.05 (1.43) | 0.48 (0.93) | 0.24 (0.62) | |
| Placebo | 4.20 (1.90) | 4.53 (2.00) | 3.85 (1.82) | 4.00 (1.81) | 4.40 (1.92) | |
| Compression | ||||||
| OMTh | 5.0 (2.2) | 3.1 (2.1) | 1.3 (1.2) | 0.6 (0.9) | 0.4 (0.7) | |
| Placebo | 5.4 (1.5) | 5.5 (1.6) | 5.4 (1.5) | 5.6 (1.6) | 5.9 (1.7) | |
| Ascending Stairs | ||||||
| OMTh | 4.29 (2.92) | 2.57 (2.68) | 1.38 (1.83) | 0.71 (1.38) | 0.57 (1.16) | |
| Placebo | 5.07 (1.91) | 5.13 (1.73) | 5.73 (1.28) | 5.60 (1.72) | 5.93 (1.94) | |
| Descending Stairs | ||||||
| OMTh | 4.90 (2.49) | 3.05 (2.38) | 1.24 (1.58) | 0.86 (1.49) | 0.52 (1.08) | |
| Placebo | 4.60 (2.16) | 4.53 (2.17) | 4.67 (2.09) | 4.67 (2.13) | 4.67 (2.13) | |
a Pain assessment was performed before the baseline (T0), second (T1), third (T2), and fourth (T3) sessions, and follow up (T4) was performed 8 weeks after T3.
Abbreviation: OMTh, osteopathic manipulative therapy (manipulative care provided by foreign-trained osteopaths).
The correlation analysis showed significant results only for the dysfunction and the compression test at T2 (P=.010, ρ=0.543). At T1, 107 somatic dysfunctions were found, and at T3, 46 were found; the somatic dysfunctions at T3 compared with T1 were decreased by 40% (Figure 1). At T3, the most improved areas were pelvic and abdominal (improvements were found in 75% and 57% of the patients treated in T2, respectively). The number of dysfunctions that were diagnosed and treated decreased during the the study period (Figure 1 and Figure 2); decreases in dysfunction were primarily found in the head and cervical, sacral, and pelvic areas.
Number and region of the assessed somatic dysfunctions. Segmental and somatic dysfunctions are coded according to the 10 anatomical regions described in the International Classification of Diseases.28
Number and region of the treated somatic dysfunctions. Segmental and somatic dysfunctions are coded according to the 10 anatomical regions described in the International Classification of Diseases.28
Discussion
The purpose of this study was to determine whether OMTh applied to somatic dysfunctions could be useful for managing the pain of patients with PFPS. We found a significant and clinically relevant reduction in the VAS score in the OMTh group compared with the placebo group after the treatment sessions and after the 2 month follow-up.33
The results of the present study are comparable to the pain reduction reported in patients with acute and chronic musculoskeletal pain.34,35 These results are also consistent with the findings of other studies,36,37 such as positive effects of adding myofascial techniques to an exercise program for patients with anterior knee pain and significant improvement in pain and functional status in patients with PFPS. It should be noted that in the present study, most of the somatic dysfunctions were also found in areas remote from the pain site, such as the head and the pelvic area, and treatments were focused only on somatic dysfunctions assessed as severe and clinically relevant. This finding was important because when a pathoanatomical source tissue cannot be identified, clinical decision-making based on a single pathological finding often leads to poor results.38 Most of the impairments that manual therapists identify in their patients are not limited to the area where the symptoms are located, but include altered processes originating from the overload of other areas or systems that, in turn, influence musculoskeletal functioning and clinical presentation.39
We found that the most improved areas were lumbar and sacral at T1, cervical and sacral at T2, and pelvic and abdominal at T3. Speculating on these findings, we can hypothesize that these improvements justify using the concept of regional interdependence, according to which a dysfunctional unit in a system may deliver abnormal stresses to different segments in the same system or in other related systems, hence favoring the establishment of new dysfunctions elsewhere.37 In other words, the aberrant mechanisms initiated and maintained by the primary dysfunctional area may induce an allostatic response involving interdependent physiological processes (such as pain) in remote areas of the body.38 Somatic dysfunction may be resolved or improved immediately after OMTh.39 Overall, patients’ comparable signs and symptoms, such as pain elicited by a compression test associated with diagnosed somatic dysfunctions, were reported to have resolved or improved after treatment sessions. These results highlight that in osteopathic care, the patient's responsiveness to provocation tests provides indications for the osteopath when choosing appropriate techniques.40 The proposed approach moves osteopathic practice from a practitioner-centered to a patient-centered approach. Diagnostic palpatory findings based on biomechanical rationale, such as positional defect, postural asymmetry, and impairments should not be considered the only aspects that can guide treatment.40 During the decision-making process, the osteopath should consider a multidimensional, neurophysiological manual examination, including the preferences and expectations of patients associated with functional outcomes.
We acknowledge that the present study has limitations. Although findings from conventional and multimodality imaging is recommended to aid in PFPS diagnosis and characterization41 in the present study, we used MRI in the recruitment phase, but there was no radiologic follow-up at the end of the treatments. For future studies, it could be interesting to correlate the reduction of the pain with morphologic MRI of the articular cartilage to investigate possible changes induced by OMTh.
One limitation of our study was that while the OMTh group received treatment in the lower extremities, the placebo procedure did not include touch of the lower extremities. This difference might have influenced results in the placebo group. Guidelines to design the most reliable placebo procedure for manual randomized control trials are needed.42 Furthermore, appropriate procedures would be useful to assess interrater agreement for the diagnosis of somatic dysfunction using the tissue texture abnormality, asymmetry, restriction of motion, and tenderness test.43
Another limitation of our study was that participants could use analgesics and muscle relaxants as needed, which could confound the data collected about pain and function. Future studies should consider patient use of a medication diary to assess whether there is an effect attributable to the medications with or without the OMTh.
The treatment of patients with anterior knee pain often involves a comprehensive evaluation that includes more outcome measures, as well as an assessment of quality of life, which is missing in this work.44,45 In future studies, we will use knee- and health-related quality of life instruments should be used to evaluate the improvements brought about by the interventions and also to clarify whether these improvements were greater than those reported for a placebo group.
Conclusion
In this preliminary study, we investigated the effects of OMTh applied to somatic dysfunction and pain in patients with PFPS. Significant differences in VAS scores were found between the OMTh and placebo groups. These findings emphasize that OMTh can lead to reduced pain in patients with PFPS. However, it is unclear whether total body OMTh is necessary vs isolated regional OMTh, or whether one technique vs another technique is more effective. More research is needed to investigate these possibilities. In any case, future studies with more outcome measures are necessary to better understand the clinical importance of these findings.
Author Contributions
All authors provided substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; Messrs Tramontano and Lunghi drafted the article or revised it critically for important intellectual content; Messrs Pagnotta and Consolo, Mss C Manzo and F Manzo, and Dr Manzo gave final approval of the version of the article to be published; and all authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
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