Categorized Physical Therapy for Hip Pain

Overseen By Jennifer Cheng

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Hospital for Special Surgery, New York

Must not be taking: TNF-alpha inhibitors

Disqualifiers: Arthritis, Spinal fusion, Inflammatory, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a specific type of physical therapy can help people with hip and groin pain not caused by arthritis. Participants will receive either a new matrix-based physical therapy combined with standard therapy or just the standard therapy alone. The goal is to determine if the new approach provides better relief. Ideal candidates for the trial are those who have recently begun experiencing non-arthritic hip or groin pain. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future treatment options.

Do I have to stop taking my current medications for the trial?

The protocol does not specify if you need to stop taking your current medications, but you cannot participate if you are taking TNF-alpha inhibitors for inflammatory conditions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes patients currently taking TNF-alpha inhibitors for inflammatory conditions.

What prior data suggests that this physical therapy protocol is safe for hip pain?

Research has shown limited specific information about the safety of matrix-based physical therapy for hip and groin pain not caused by arthritis. However, physical therapy is generally considered a safe treatment. It typically includes exercises and hands-on techniques to improve movement and reduce pain. Studies have not reported any serious side effects from physical therapy.

This trial is labeled as "Not Applicable" in terms of phase, indicating it does not involve a new drug or invasive treatment, which usually suggests fewer safety concerns. Physical therapy is generally safe, with the most common issues being temporary muscle soreness or mild discomfort.

For those considering joining the trial, the non-invasive nature of the therapy is a positive indicator of safety. It is advisable to consult with a doctor or the trial team for any questions or concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about matrix-based physical therapy for hip pain because it offers a personalized approach that tailors exercises to the patient’s specific needs, unlike standard physical therapy which often uses a more generic regimen. This method focuses on individualized movement patterns, potentially leading to quicker and more effective pain relief and improved mobility. By addressing the root causes of hip pain with customized interventions, matrix-based therapy could significantly enhance recovery outcomes compared to traditional methods.

What evidence suggests that this trial's physical therapy treatments could be effective for hip pain?

Studies have shown that physical therapy can alleviate hip pain. However, limited research exists on matrix-based therapy for hip and groin pain not caused by arthritis. This trial will compare matrix-based physical therapy, which groups patients by factors like hip stiffness or strength for personalized treatment, with standard-of-care physical therapy. Specifically, people with long-term hip pain have experienced lasting improvement after receiving customized physical therapy. While matrix-based therapy holds promise, more research is needed to confirm its effectiveness for non-arthritic conditions. ^{1 3 5 6 7}

Who Is on the Research Team?

Peter Moley, MD

Principal Investigator

Hospital for Special Surgery, New York

Are You a Good Fit for This Trial?

This trial is for new patients aged 18-60 with non-arthritic hip and groin pain (Tonnis grade 0-1). It's not suitable for those under 18 or over 60, anyone who has had hip surgery, speaks no English, suffers from inflammatory conditions or other joint issues that could affect the therapy, takes TNF-alpha inhibitors, has arthritic hip pain (Tonnis grade 2+), radicular back pain, prior knee osteotomy or spinal fusion surgery.

Inclusion Criteria

I have hip and groin pain without arthritis (Tonnis grade 0-1).

Exclusion Criteria

I have had spinal fusion surgery.

I have moderate to severe hip arthritis.

I have had surgery to realign my knee.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive matrix-based physical therapy and standard-of-care physical therapy

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Matrix-based physical therapy
• Standard-of-care physical therapy

Trial Overview The study compares two types of physical therapy treatments for non-arthritic hip and groin pain. One group will receive a matrix-based physical therapy protocol while the other will undergo standard-of-care physical therapy to see which is more effective in managing their condition.

How Is the Trial Designed?

Group I: Matrix-Based PT Experimental Treatment 2 Interventions

Patients will receive matrix-based physical therapy, in addition to standard-of-care physical therapy.

Group II: Control Active Control 1 Intervention

Patients will receive standard-of-care physical therapy.

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

Published Research Related to This Trial

In a study involving 78 adults with nonarthritic hip pain, an interdisciplinary evaluation that included both a surgeon and a physical therapist led to a 6.3-point reduction in decisional conflict regarding treatment plans compared to standard evaluations, indicating improved clarity in decision-making.

While 66% of participants who received the interdisciplinary evaluation considered physical therapy in their treatment plan, this increase was not statistically significant, suggesting that while the approach is feasible, further research is needed to confirm its impact on treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment decisions after interdisciplinary evaluation for nonarthritic hip pain: A randomized controlled trial. Brown-Taylor, L., Harris-Hayes, M., Foraker, R., et al.[2023]

Physical therapy can be an effective treatment option for hip pain when arthritis has been ruled out, focusing on improving strength, movement, and balance.

Rehabilitation clinicians will use specific leg strength and balance tests to tailor exercises that help alleviate hip pain and enhance overall function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hip Pain and Physical Therapy Nonarthritic Hip Pain: What Is It? What Should I Do About It? How Do I Get Back to My Regular Activities? [2023]

In a study of 201 pediatric patients with anterior hip pain, adding manual therapy (MT) to physical therapy did not improve pain efficiency compared to those who received physical therapy alone, with pain efficiency scores of 0.60 for MT and 0.80 for no MT.

There was no increase in the risk of adverse reactions associated with manual therapy, indicating it is a safe intervention for this patient group, with both groups experiencing similar rates of adverse reactions (5 each).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of manual physical therapy interventions in pediatric patients with anterior hip pain: a retrospective study. Galleher, M., Crowe, B., Selhorst, M.[2022]

A hip school program led by physical therapists significantly reduced pain and activity limitations in patients with hip dysfunction, as measured by the WOMAC index, after 6 months compared to a control group.

Improvements in health-related quality of life, including sleep disturbances and physical mobility, were also observed in the treatment group and persisted for an additional 6 months, indicating the long-term benefits of the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promising outcome of a hip school for patients with hip dysfunction. Klässbo, M., Larsson, G., Harms-Ringdahl, K.[2022]

In a study of 46 patients with chronic hip-related groin pain, both physical therapist-led interventions (movement pattern training and traditional strength/flexibility) resulted in significant and sustained improvements in hip function and pain levels, measured at 6 and 12 months after treatment.

The majority of participants (93.5%) completed the treatment, and both groups showed clinically significant improvements in various outcome measures, indicating that these interventions are effective for managing chronic hip-related groin pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year outcomes following physical therapist-led intervention for chronic hip-related groin pain: Ancillary analysis of a pilot multicenter randomized clinical trial. Harris-Hayes, M., Steger-May, K., M Bove, A., et al.[2022]

A feasibility randomized clinical trial involving 35 patients with chronic hip joint pain showed high retention (89% for the treatment group) and adherence (89% attending at least 80% of sessions) to a movement-pattern training (MPT) program, indicating that a larger trial is practical.

Secondary outcomes suggested that MPT may improve patient-reported function and hip muscle strength, supporting the need for a more extensive study to evaluate its effectiveness compared to a control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Movement-Pattern Training to Improve Function in People With Chronic Hip Joint Pain: A Feasibility Randomized Clinical Trial. Harris-Hayes, M., Czuppon, S., Van Dillen, LR., et al.[2022]

A standardized treatment program for physical therapy after total hip or knee replacement was developed through a consensus process involving 18 clinicians, emphasizing key areas like exercise, transfers, ambulation, and discharge criteria.

The final treatment protocols were accepted by a significant majority of the panel (76% for hip replacements and 70% for knee replacements), which helps establish a baseline standard of care for patients undergoing these surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total hip and knee replacement treatment programs: a report using consensus. Enloe, LJ., Shields, RK., Smith, K., et al.[2005]

In a study of 147 total hip arthroplasty (THA) patients, it was found that women generally start physical therapy with lower functional status than men, even though their recovery patterns are similar when therapy begins within 9 weeks post-surgery.

Patients who started physical therapy less than 9 weeks after surgery showed steady improvement in functional status over 26 weeks, indicating that early intervention may enhance recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating Research into Clinical Practice: Functional Recovery Post Total Hip Arthroplasty Using Outcomes Gathered in the Usual Physical Therapy Practice Setting. Kirkness, CS., Fritz, JM.[2022]

Orthopaedic physical therapy is generally considered safe, but there is a lack of high-quality data documenting its safety, particularly regarding cervical manipulation, highlighting the need for more rigorous research on potential harms.

Current research shows poor reporting standards for adverse events in orthopaedic physical therapy, indicating a need for standardized terminology and better documentation practices to ensure informed consent and clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardization of adverse event terminology and reporting in orthopaedic physical therapy: application to the cervical spine. Carlesso, LC., Macdermid, JC., Santaguida, LP.[2022]

The APTA's Orthopaedic Section is developing evidence-based practice guidelines specifically for managing nonarthritic hip joint pain, focusing on musculoskeletal impairments.

These guidelines aim to summarize peer-reviewed literature to provide clear recommendations for physical therapy interventions, enhancing the quality of care for patients with hip joint issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonarthritic hip joint pain. Enseki, K., Harris-Hayes, M., White, DM., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04720846

Categorized PT for Non-arthritic Hip and Groin Pain Matrix-based physical therapy will be physical therapy that is based on the matrix categorization of the patient (stiff vs. mobile hips, weak vs. strong hips) ...

2. withpower.com withpower.com/trial/phase-11-2020-ecb64

Categorized Physical Therapy for Hip Pain Based on the gap in the literature, this study will aim to assess the effect of matrix-based standard of care therapy in patients presenting with non-arthritic ...

3. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04720846?keyword=%22Hip%20Pain%22

Categorized PT for Non-arthritic Hip and Groin Pain However, there are no studies observing the effect of a standardized physical therapy program on patients presenting with non-arthritic hip and groin pain.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4399382/

Non-arthritic Hip Joint Pain - PubMed Central - NIH Describe evidence-based physical therapy practice including diagnosis, prognosis, intervention, and assessment of outcome for musculoskeletal disorders ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33458839/

Ancillary analysis of a pilot multicenter randomized clinical trial Among patients with chronic HRGP, both MoveTrain and Standard resulted in improved outcomes that were sustained 12 months after treatment.

6. clinicaltrial.be clinicaltrial.be/en/details/48447?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Categorized PT for Non-arthritic Hip and Groin Pain - Cli... Based on the gap in the literature, this study will aim to assess the effect of matrix-based standard of care therapy in patients presenting ...

7. ctv.veeva.com ctv.veeva.com/study/categorized-pt-for-non-arthritic-hip-and-groin-pain

Categorized PT for Non-arthritic Hip and Groin Pain Based on the gap in the literature, this study will aim to assess the effect of matrix-based standard of care therapy in patients presenting ...