Skip to main content
OpenTrials
Completed

NCT Number: NCT03959319

Comparison of Movement Pattern Training and Manual Therapy for Prearthritic Hip Disorders

Significance: Intra-articular, prearthritic hip disorders (PAHD) result in substantial dysfunction in young adults and are proposed precursors to hip osteoarthritis (OA). Our long term goal is to develop effective treatment strategies for people with PAHD that will improve function, decrease pain and prevent or delay the onset of OA. The purpose of this study is to compare movement pattern training (MoveTrain) and manual therapy (ManTher) in their effect on post-treatment, patient-reported outcomes and targeted impairments thought to contribute to PAHD.

This pilot study will collect sufficient data to power a future study that will determine the efficacy of MoveTrain compared to ManTher for people with PAHD. Participants with PAHD will be randomized into one of two treatment groups, MoveTrain or ManTher. The Hip disability and Osteoarthritis Outcome Score (HOOS) will be the primary outcome measure. A measure of hip adduction motion during functional tasks and quantitative sensory assessment (pain pressure threshold and temporal summation) will be the secondary measures used to assess the effect of respective treatment on the impairments thought to contribute to PAHD, thus addressing the mechanisms of pain. Upon completion of this study, we will be positioned to implement a large RCT (randomized clinical trial) to definitively assess the efficacy of MoveTrain and ManTher to improve PAHD.

Specific Aims: To obtain preliminary estimates of effect sizes for planning the future definitive randomized clinical trial,

Aim 1 (Function): we will compare post-treatment improvements in hip-specific, patient-reported outcomes among the two treatment groups. After treatment completion:

Aim 2 (Mechanism): we will compare pre- and post-treatment measures in lower extremity movement patterns during functional tasks (MoveTrain) and quantitative sensory testing (ManTher). After treatment completion:

Aim 3 (Prognosis): we will determine the association among personal factors at baseline (demographic and psychosocial) and treatment prognosis (improvement in HOOS).

Impact: Our line of research will improve our understanding of each proposed treatment and its effect on patient function and each treatment's targeted impairment. This improved understanding will lead to the development of treatment strategies that will ultimately result in comparative effectiveness studies of surgical and non-surgical treatment.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hip-related Groin Pain Dysplasia Mild Femoracetabular Impingement Femoroacetabular Impingement Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Prearthritic Hip Disorder

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Program in Physical Therapy, Washington University

St Louis, Missouri, 63108, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-40 years
  • Must be scheduled before their 40th birthday
  • Have frequent hip joint symptoms, defined as pain, aching or stiffness within the hip joint for at least 3 months during the past 12 months
  • Hip joint pain confirmed upon physical exam
  • Report pain >= 3/10
  • Reports functional limitation as demonstrated by modified Harris Hip Score <90
  • Has protective sensation in the feet

Exclusion criteria

  • Previous hip surgery, fracture, pelvic/hip infection or cancer
  • Pain due to high impact trauma
  • Inflammatory disease, e.g. rheumatoid arthritis, gout
  • Acute pain in another joint that limits functional activities
  • Perthes disease or slipped capital femoral epiphysis
  • Hip pain referred from another source, e.g. lumbar spine
  • Neurological involvement affecting balance or coordination
  • Use of assistive gait device for more than 50% of time walking
  • Pain, numbness or tingling in the lower extremity
  • Pregnancy or given birth in previous 12 weeks
  • Unwilling to refrain from taking NSAIDs 1-2 days prior to testing session
  • Unable to attend regular physical therapy sessions
  • Unable to complete 12 month follow up session
  • Avascular Necrosis
  • Ehler's Danlos Syndrome

Treatment and study plan

Movement Pattern Training

Other

Treatment will include 10 supervised sessions over 12 weeks and instruction in a home exercise program After randomization, participants will be scheduled with a physical therapist trained in standard procedures. Treatment will include assessment of patient goals, patient education and instruction in a home program. Patient education will focus on patient-specific tasks, identified by the participant to be symptom-producing.

Manual therapy

Other

Treatment will include 10 supervised sessions over 12 weeks and instruction in a home exercise program After randomization, participants will be scheduled with a physical therapist trained in standard procedures. Treatment will include assessment of patient goals, patient education and instruction in a home program. Patient education will focus on patient-specific tasks, identified by the participant to be symptom-producing.

Other names: Joint Mobilization

Primary outcomes

  1. Change in Function Using the Hip disability and Osteoarthritis Outcome Score Activities of Daily Living Subscale

    Time frame: Immediately after treatment (13 weeks after baseline)

    The Hip disability and Osteoarthritis Outcome Score (HOOS) is a hip-specific patient-reported outcome measure that has 5 subscales. Each subscale is score separately and ranges from 0-100, 100 = no disability, therefore higher values indicate a better outcome.

  2. Change in Function Using the Hip disability and Osteoarthritis Outcome Score Symptom Subscale

    Time frame: Immediately after treatment (13 weeks after baseline)

    The Hip disability and Osteoarthritis Outcome Score (HOOS) is a hip-specific patient-reported outcome measure that has 5 subscales. Each subscale is score separately and ranges from 0-100, 100 = no disability, therefore higher values indicate a better outcome.

  3. Percentage of Participants Who Are Adherent to Treatment Attendance

    Time frame: Immediately after treatment (13 weeks after baseline)

    Percentage of study participants who attend 90% (9/10) of the supervised treatment sessions.

  4. Retention Rate

    Time frame: Immediately after treatment (13 weeks after baseline)

    Percentage of those enrolled at baseline who completed testing after treatment

Secondary outcomes

  1. Home Exercise Program (HEP) adherence

    Time frame: Immediately after treatment (13 weeks after baseline)

    Participants were instructed to perform their HEP 5 times per week1 time per day. The variable for HEP adherence was calculated as the total number of days reported by the participant to have completed the prescribed exercises, summed over the entire treatment period, and divided by the total number of treatment days.

  2. Patient treatment receipt

    Time frame: Immediately after treatment (13 weeks after baseline)

    The total number of exercises the physical therapist reviewed and the total number of those exercises they rated as independent were each summed across all treatment visits to derive the percent of exercises rated as independent across the entire treatment (Σ independent / Σ reviewed * 100).

  3. Active ingredients for treatment delivery

    Time frame: Immediately after treatment (13 weeks after baseline)

    Treatment delivery assessed using chart reviews to determine if the active ingredients of the treatment was provided. The variable for treatment delivery is the proportion of active ingredients completed and documented by the treatment physical therapists for XX treatment visits

  4. Change in hip adduction angle

    Time frame: Immediately after treatment (13 weeks after baseline)

    Change in hip adduction angle during functional tasks. Variable to assess movement pattern changes.

  5. Change in hip adduction angle

    Time frame: On year after treatment completion

    Change in hip adduction angle during functional tasks. Variable to assess movement pattern changes.

  6. Change in pain pressure threshold

    Time frame: Immediately after treatment (13 weeks after baseline)

    Pain pressure threshold is assessed with an algometer. This is a quantitative sensory testing to assess the patient's sensitivity to stimuli.

  7. Change in pain pressure threshold

    Time frame: One year after treatment completion

    Pain pressure threshold is assessed with an algometer. This is a quantitative sensory testing to assess the patient's sensitivity to stimuli.

  8. Change in Function Using the Hip disability and Osteoarthritis Outcome Score Pain Subscale

    Time frame: Immediately after treatment (13 weeks after baseline)

    The Hip disability and Osteoarthritis Outcome Score (HOOS) is a hip-specific patient-reported outcome measure that has 5 subscales. Each subscale is score separately and ranges from 0-100, 100 = no disability, therefore higher values indicate a better outcome.

  9. Change in Function Using the Hip disability and Osteoarthritis Outcome Score Pain Subscale

    Time frame: One year after treatment completion

    The Hip disability and Osteoarthritis Outcome Score (HOOS) is a hip-specific patient-reported outcome measure that has 5 subscales. Each subscale is score separately and ranges from 0-100, 100 = no disability, therefore higher values indicate a better outcome.

  10. Change in Function Using the Hip disability and Osteoarthritis Outcome Score Sport and Recreation Subscale

    Time frame: Immediately after treatment (13 weeks after baseline)

    The Hip disability and Osteoarthritis Outcome Score (HOOS) is a hip-specific patient-reported outcome measure that has 5 subscales. Each subscale is score separately and ranges from 0-100, 100 = no disability, therefore higher values indicate a better outcome.

  11. Change in Function Using the Hip disability and Osteoarthritis Outcome Score Sport and Recreation Subscale

    Time frame: One year after treatment completion

    The Hip disability and Osteoarthritis Outcome Score (HOOS) is a hip-specific patient-reported outcome measure that has 5 subscales. Each subscale is score separately and ranges from 0-100, 100 = no disability, therefore higher values indicate a better outcome.

  12. Change in Function Using the Hip disability and Osteoarthritis Outcome Score Quality of Life Subscale

    Time frame: Immediately after treatment (13 weeks after baseline)

    The Hip disability and Osteoarthritis Outcome Score (HOOS) is a hip-specific patient-reported outcome measure that has 5 subscales. Each subscale is score separately and ranges from 0-100, 100 = no disability, therefore higher values indicate a better outcome.

  13. Change in Function Using the Hip disability and Osteoarthritis Outcome Score Quality of Life Subscale

    Time frame: One year after treatment completion

    The Hip disability and Osteoarthritis Outcome Score (HOOS) is a hip-specific patient-reported outcome measure that has 5 subscales. Each subscale is score separately and ranges from 0-100, 100 = no disability, therefore higher values indicate a better outcome.

  14. Change in Function Using the Hip disability and Osteoarthritis Outcome Score Activities of Daily Living Subscale

    Time frame: One year after treatment completion

    The Hip disability and Osteoarthritis Outcome Score (HOOS) is a hip-specific patient-reported outcome measure that has 5 subscales. Each subscale is score separately and ranges from 0-100, 100 = no disability, therefore higher values indicate a better outcome.

  15. Change in Function Using the Hip disability and Osteoarthritis Outcome Score Symptom Subscale

    Time frame: One year after treatment completion

    The Hip disability and Osteoarthritis Outcome Score (HOOS) is a hip-specific patient-reported outcome measure that has 5 subscales. Each subscale is score separately and ranges from 0-100, 100 = no disability, therefore higher values indicate a better outcome.

  16. Change in movement evoked pain

    Time frame: Immediately after treatment (13 weeks after baseline)

    Movement evoked pain was assessed as a Numeric Pain Rating Scale (NPRS) after performance of a repetitive step down task and a repetitive deep squat task.

  17. Change in movement evoked pain

    Time frame: One year after treatment completion

    Movement evoked pain was assessed as a Numeric Pain Rating Scale (NPRS) after performance of a repetitive step down task and a repetitive deep squat task.

  18. Change in Function Using the International Hip Outcome Tool (iHOT-33)

    Time frame: Immediately after treatment (13 weeks after baseline)

    The iHOT is a hip-specific patient-reported outcome measure that represents the patient's report of symptoms, activity limitations, as well as emotional and social status. the score ranges from 0-100, 100 = no disability, therefore higher values indicate a better outcome.

  19. Change in Function Using the International Hip Outcome Tool (iHOT-33)

    Time frame: One year after treatment completion

    The iHOT is a hip-specific patient-reported outcome measure that represents the patient's report of symptoms, activity limitations, as well as emotional and social status. the score ranges from 0-100, 100 = no disability, therefore higher values indicate a better outcome.

  20. Change in Function Using the Patient Specific Functional Scale From Baseline to Post-treatment (13 Weeks)

    Time frame: Immediately after treatment (13 weeks after baseline)

    The Patient Specific Functional Scale (PSFS), a patient-reported outcome measure of patient-specific activity limitations. Patients are asked to identify "3-5 activities you are unable to do or having difficulties performing due to the pain or symptoms in your hip". Patients then rated level of difficulty from 0-10, 0 indicating they are unable to perform the activity and 10 indicating they are able to perform the activity at their preinjury level. The final score is an average of all scores provided. Change was calculated by subtracting the baseline PSFS from the post-treatment PSFS.

  21. Change in Function Using the Patient Specific Functional Scale From Baseline to Post-treatment

    Time frame: One year after treatment completion

    The Patient Specific Functional Scale (PSFS), a patient-reported outcome measure of patient-specific activity limitations. Patients are asked to identify "3-5 activities you are unable to do or having difficulties performing due to the pain or symptoms in your hip". Patients then rated level of difficulty from 0-10, 0 indicating they are unable to perform the activity and 10 indicating they are able to perform the activity at their preinjury level. The final score is an average of all scores provided. Change was calculated by subtracting the baseline PSFS from the post-treatment PSFS.

  22. Change in Average Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment

    Time frame: Immediately after treatment (13 weeks after baseline)

    The numeric pain rating scale (NPRS) is a patient-reported outcome measure of pain intensity quantified using a 0-10 scale, 0 indicating the patient perceives no pain and 10 indicating the patient perceives the pain to be "worst pain imaginable". For average NPRS, patients are asked to rate what their pain was over the last week. Change was calculated by subtracting the baseline average NPRS from the post-treatment average NPRS.

  23. Change in Average Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment

    Time frame: One year after treatment completion

    The numeric pain rating scale (NPRS) is a patient-reported outcome measure of pain intensity quantified using a 0-10 scale, 0 indicating the patient perceives no pain and 10 indicating the patient perceives the pain to be "worst pain imaginable". For average NPRS, patients are asked to rate what their pain was over the last week. Change was calculated by subtracting the baseline average NPRS from the post-treatment average NPRS.

  24. Change in Worst Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment

    Time frame: Immediately after treatment (13 weeks after baseline)

    The numeric pain rating scale (NPRS) is a patient-reported outcome measure of pain intensity quantified using a 0-10 scale, 0 indicating the patient perceives no pain and 10 indicating the patient perceives the pain to be "worst pain imaginable". For worst NPRS, patients are asked to rate what was their worst (highest) level of pain was over the last week. Change was calculated by subtracting the baseline worst NPRS from the post-treatment worst NPRS.

  25. Change in Worst Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment

    Time frame: One year after treatment completion

    The numeric pain rating scale (NPRS) is a patient-reported outcome measure of pain intensity quantified using a 0-10 scale, 0 indicating the patient perceives no pain and 10 indicating the patient perceives the pain to be "worst pain imaginable". For worst NPRS, patients are asked to rate what was their worst (highest) level of pain was over the last week. Change was calculated by subtracting the baseline worst NPRS from the post-treatment worst NPRS.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Foundation for Physical Therapy, Inc.

Registry information

Official study title

Comparison of Movement Pattern Training and Manual Therapy for Prearthritic Hip Disorders: a Pilot Randomized Clinical Trial

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 22, 2019
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.