Hip-related Groin Pain, Femoroacetabular Impingement, Dysplasia Mild, Prearthritic Hip Disorder
Conditions
Keywords
clinical trial, rehabilitation, joint mobilization, movement training
Brief summary
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.
Interventions
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.
OTHERManual Therapy
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.
Sponsors
Foundation for Physical Therapy, Inc.
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The principle investigator and research staff who will be completing outcome assessments and measurements will be blinded to treatment group. Given the nature of the treatment, it is not possible to blind the care provider or the participant from the treatment group.
Intervention model description
Participants will complete self-report questionnaires and participate in a clinical examination that will include movement pattern, range of motion and quantitative sensory assessment. Participants will be randomized into one of two treatment groups, movement pattern training (MoveTrain) or manual therapy (ManTher). Both groups will participate in 10 supervised sessions within a 12 week time frame. MoveTrain will include task-specific training to optimize biomechanics during daily tasks and patient-specific tasks including work and fitness. ManTher will include select manual techniques including joint and soft tissue mobilization. Both groups will receive a home exercise program. At 13 weeks after enrollment, participants will return for testing to assess post-treatment improvements in primary and secondary outcomes. We also obtain 6 and 12 month questionnaires to assess patient outcomes.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Function Using the Hip disability and Osteoarthritis Outcome Score Activities of Daily Living Subscale | 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. |
| Change in Function Using the Hip disability and Osteoarthritis Outcome Score Symptom Subscale | 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. |
| Percentage of Participants Who Are Adherent to Treatment Attendance | Immediately after treatment (13 weeks after baseline) | Percentage of study participants who attend 90% (9/10) of the supervised treatment sessions. |
| Retention Rate | Immediately after treatment (13 weeks after baseline) | Percentage of those enrolled at baseline who completed testing after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain pressure threshold | 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. |
| Change in Function Using the Hip disability and Osteoarthritis Outcome Score Pain Subscale | 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. |
| Change in Function Using the Hip disability and Osteoarthritis Outcome Score Sport and Recreation Subscale | 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. |
| Change in Function Using the Hip disability and Osteoarthritis Outcome Score Quality of Life Subscale | 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. |
| Change in Function Using the Hip disability and Osteoarthritis Outcome Score Activities of Daily Living Subscale | 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. |
| Change in Function Using the Hip disability and Osteoarthritis Outcome Score Symptom Subscale | 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. |
| Home Exercise Program (HEP) adherence | 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. |
| Change in Function Using the International Hip Outcome Tool (iHOT-33) | 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. |
| Change in Function Using the Patient Specific Functional Scale From Baseline to Post-treatment (13 Weeks) | 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. |
| Change in Function Using the Patient Specific Functional Scale From Baseline to Post-treatment | 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. |
| Change in Average Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment | 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. |
| Change in Worst Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment | 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. |
| Change in movement evoked pain | 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. |
| Patient treatment receipt | 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). |
| Active ingredients for treatment delivery | 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 |
| Change in hip adduction angle | Immediately after treatment (13 weeks after baseline) | Change in hip adduction angle during functional tasks. Variable to assess movement pattern changes. |
Countries
United States
Outcome results
None listed