Hip Injuries, Pain, Therapy/Rehabilitation
Conditions
Brief summary
Greater trochanteric pain syndrome (GTPS), or lateral hip pain, is associated with muscle weakness, altered movement patterns and painful daily activities. The disability associated with GTPS is comparable to end stage hip osteoarthritis, primarily affecting young and middle aged women. Few non-operative treatments have demonstrated long-term lasting or satisfactory results. For those who do improve, recurrence rates of pain and disability can be as high as 50%. Gluteal tendinopathy is the most common condition associated with a GTPS diagnosis. High compressive loads of the gluteal tendons during common activities like walking, stair-climbing, and running are the theorized mechanism for GTPS. These compressive loads are exacerbated with postures and movement patterns that involve the lateral tilting of the pelvis or movement of the thigh across the midline of the body. There is recent evidence that load modification through education and exercise is superior to a corticosteroid injection for reducing pain in these patients. However, it is unknown whether the possible effects of the load modification program were due to exercise alone or the reduction in compressive loads. As current physical therapy interventions for GTPS commonly incorporate high load postures and exercise activities, there is an urgent need to compare outcomes of standard of care physical therapy to load modification. The goal of this study is to evaluate the short-term effects of load modification education on pain and function in individuals with GTPS. Participants will be randomized to receive either standard exercise education or load modification education. Both groups will complete a series of questionnaires about their pain and function, and undergo a brief 2-dimensional assessment of their posture and movement. Between follow-up sessions, participants will be asked to respond to brief weekly online surveys to document their home program compliance, pain, and function. It is hypothesized that the group of participants receiving load modification will have the highest proportion of individuals with significant improvements in pain and function, and will demonstrate improved posture and movement.
Interventions
OTHERLoad modification education
Load modification education includes exercises currently prescribed by physical therapists, like stretching and strengthening activities, but will also include education on common daily postures and movement patterns that may increase load and stress on the muscles and tendons around the hip.
Standard exercise education includes exercises currently prescribed by physical therapists, like stretching and strengthening activities.
Sponsors
Foundation for Physical Therapy Research
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Unilateral diagnosis of GTPS, as confirmed by physician using the following criteria: * Lateral hip pain, worst over greater trochanter, for \>/= 3 months * Pain with palpation over greater trochanter * Average pain intensity of \>/= 4/10 most days of the week * Lateral hip pain reproduced during a 30 second single leg stance, or at least one of the following positive tests: 1. \>/= 2/10 lateral hip pain reproduce with passive hip flexion, adduction, and external rotation (ie. FADER) 2. lateral hip pain reproduced with resisted internal rotation in the passive hip flexion, adduction, and external rotation position (ie. FADER-R) 3. lateral hip pain reproduce with overpressure into passive hip adduction in sidelying (ie. ADD) 4. lateral hip pain reproduced with resisted hip abduction in the hip hip adducted position (ie. ADD-R) 5. lateral hip pain reproduced with hip flexion, abduction, external rotation (ie. FABER)
Exclusion criteria
<!-- --> 1. Any of the following treatments within the last 3 months: 1. corticosteroid injection in the affected hip 2. physical therapy or other skilled exercise intervention by a medical or rehabilitation professional 2. Any of the following concomitant impairments or conditions: a) Known or observed advanced spine, hip, knee, or ankle joint pathology, including: i. Spinal or lower extremity surgery within the last 6 months ii. Imaging data showing Kellgren Lawrence grade \>/=2 in any lower extremity joint with concurrent complaint \>/=2/10 most days of the week. iii. Groin pain as the primary hip pain complaint \>/=2/10 most days of the week. iv. \<90 degrees of active hip and knee flexion bilaterally v. \<0 degrees of active ankle dorsiflexion b) Systemic inflammatory diseases, or any systemic disease that affects the nervous or musculoskeletal system or uncontrolled diabetes, or active malignancy c) Individuals who cannot tolerate or should not assume the positions required for the exercises for any reason other than hip discomfort
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Rating of Change | 4 weeks after enrollment | Participant perception of functional change, measured on an 11-point likert scale from 'very much worse' (minimum, worse outcome) to 'very much better' (maximum, better outcome). Results were then dichotomized into those who indicated they were at least 'moderately better' and those who did not. |
| Change in Numeric Pain Rating Scale | at the time of enrollment and 4 weeks after enrollment | The Numeric Pain Rating Scale (NPRS) is a self-report survey of a participant's worst hip pain in the last week on an 11-point (0-10) scale, where 0 is no pain, 10 is the worst pain imaginable. The Change in NPRS is calculated by subtracting the baseline NPRS from the 4-week NPRS. A positive response to treatment was defined less than or equal to -2 (i.e., pain reduction by 2 points). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Bank v2.0 Physical Function | at the time of enrollment and 4 weeks after enrollment | The Patient Reported Outcomes Measurement Information System Bank v2.0 Physical Function assesses self-reported physical function of respondents using computerized adaptive testing techniques. It uses responses to each item to calculate a T-score and it is recommended that scoring occur in REDCapTM or similar scoring service to calculate scores using response pattern scoring. The mean score for adults in the United States is 50 with a standard deviation of 10. Higher T-scores are associated with better function and lower T-scores are associated with worse physical function, and T-scores generally range from 20-80. We used the change in PROMIS-PF from the time of enrollment to 4 weeks after enrollment. |
| Change in Pain Self-Efficacy Questionnaire (PSEQ) | at the time of enrollment and 4 weeks after enrollment | The Pain Self-Efficacy Questionnaire is a 10-question survey about confidence with activities of daily living, and each question uses a 7-point likert scale, where 0 represents not at all confident and 6 represents completely confident. Answers to each of the 10 questions are summed to generate a total score. Higher scores represent a better outcome; the best score is 60, the worst score is 0. We used the change in PSEQ from the time of enrollment to 4 weeks after enrollment. |
| Patient Acceptable Symptomatic State Question | 4 weeks after enrollment | The Patient Acceptable Symptomatic State is a single question (yes/no response) asking respondents whether or not they are satisfied with their current state, considering all daily activities, their level of pain, and perceived functional impairment. Selecting 'Yes' would indicate the respondent is satisfied with their current state, selecting 'No' would indicate the respondent is not satisfied with their current state. |
| Tegner Activity Level Scale | 4 weeks after enrollment | Tegner Activity Level Scale is a self-report scale of physical activity. The scale has 11 categorical options ranging from complete disability/inactivity (0) to national elite-level sports (11). The best score is 11, indicating elite-level activity participation. |
| Change in Victorian Institute of Sport Assessment for Greater Trochanteric Pain Syndrome (VISA-G) | at the time of enrollment and 4 weeks after enrollment | The Victorian Institute of Sport Assessment for Greater Trochanteric Pain Syndrome is a 8-question survey about perceived hip pain and associated functional limitations during various daily activities. Question 1 asks respondents about their usual hip pain severity, scored from 0-10 (1-unit intervals), with 0 represent the worst pain. Questions 2-7 have 5 options that are scored 0, 2, 5, 7, or 10 points, with 0's representing extreme difficulty or inability and 10's representing no difficulty with the activity. Question 8 requires respondents to choose one subsection (A, B, or C) that best corresponds with how their hip pain affects their exercise; the minimum score is 0, the maximum is 30. To calculate the total score, scores from each question are summed. Higher total scores represent a better outcome; the best score is 100, the worst score is 0. We used the change in VISA-G from the time of enrollment to 4 weeks after enrollment. |
Countries
United States
Participant flow
Pre-assignment details
One individual was enrolled and then withdrawn by the study team prior to randomization because they had a systemic condition that met study exclusion criteria. Part of our eligibility assessment process was to consent individuals prior to asking additional questions about their hip problem and other health conditions. We called this our 'step-step' eligibility verification process, and those participants who disclosed information that excluded them from study participation were withdrawn.
Participants by arm
| Arm | Count |
|---|---|
| Load Modification Education Load modification education includes exercises currently prescribed by physical therapists, like stretching and strengthening activities, but will also include education on common daily postures and movement patterns that may increase load and stress on the muscles and tendons around the hip.
Load modification education: Load modification education includes exercises currently prescribed by physical therapists, like stretching and strengthening activities, but will also include education on common daily postures and movement patterns that may increase load and stress on the muscles and tendons around the hip. | 31 |
| Standard Exercise Education Standard exercise education includes exercises currently prescribed by physical therapists, like stretching and strengthening activities.
Standard exercise education: Standard exercise education includes exercises currently prescribed by physical therapists, like stretching and strengthening activities. | 30 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Incomplete primary outcome data | 2 | 0 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Protocol Violation | 2 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Load Modification Education | Standard Exercise Education | Total |
|---|---|---|---|
| Age, Continuous | 54.4 years | 57.0 years | 55.9 years |
| Body Mass Index | 29.2 kg/m^2 STANDARD_DEVIATION 9.2 | 30.1 kg/m^2 STANDARD_DEVIATION 7.2 | 29.7 kg/m^2 STANDARD_DEVIATION 8.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 27 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 5 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 25 Participants | 23 Participants | 48 Participants |
| Region of Enrollment United States | 31 Participants | 30 Participants | 61 Participants |
| Sex: Female, Male Female | 26 Participants | 23 Participants | 49 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 25 |
| other Total, other adverse events | 1 / 23 | 0 / 25 |
| serious Total, serious adverse events | 0 / 23 | 0 / 25 |
Outcome results
Primary
Change in Numeric Pain Rating Scale
The Numeric Pain Rating Scale (NPRS) is a self-report survey of a participant's worst hip pain in the last week on an 11-point (0-10) scale, where 0 is no pain, 10 is the worst pain imaginable. The Change in NPRS is calculated by subtracting the baseline NPRS from the 4-week NPRS. A positive response to treatment was defined less than or equal to -2 (i.e., pain reduction by 2 points).
Time frame: at the time of enrollment and 4 weeks after enrollment
Population: We included individuals who had baseline and 4-week Numeric Pain Rating Scale data, and 4-week Global Rating of Change data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Load Modification Education | Change in Numeric Pain Rating Scale | reported at least 2 point decrease in pain | 10 Participants |
| Load Modification Education | Change in Numeric Pain Rating Scale | did not report at least 2 point decrease in pain | 13 Participants |
| Standard Exercise Education | Change in Numeric Pain Rating Scale | did not report at least 2 point decrease in pain | 15 Participants |
| Standard Exercise Education | Change in Numeric Pain Rating Scale | reported at least 2 point decrease in pain | 10 Participants |
Primary
Global Rating of Change
Participant perception of functional change, measured on an 11-point likert scale from 'very much worse' (minimum, worse outcome) to 'very much better' (maximum, better outcome). Results were then dichotomized into those who indicated they were at least 'moderately better' and those who did not.
Time frame: 4 weeks after enrollment
Population: All participants with Global Rating of Change data at 4 weeks, who also had Numeric Pain Rating Scale data at baseline and 4-weeks.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Load Modification Education | Global Rating of Change | At least 'moderately better' | 7 Participants |
| Load Modification Education | Global Rating of Change | Were not at least 'moderately better' | 16 Participants |
| Load Modification Education | Global Rating of Change | Did not complete the question | 0 Participants |
| Standard Exercise Education | Global Rating of Change | At least 'moderately better' | 3 Participants |
| Standard Exercise Education | Global Rating of Change | Were not at least 'moderately better' | 21 Participants |
| Standard Exercise Education | Global Rating of Change | Did not complete the question | 1 Participants |
p-value: 0.87995% CI: [0.36, 3.35]Chi-squared
Secondary
Change in Pain Self-Efficacy Questionnaire (PSEQ)
The Pain Self-Efficacy Questionnaire is a 10-question survey about confidence with activities of daily living, and each question uses a 7-point likert scale, where 0 represents not at all confident and 6 represents completely confident. Answers to each of the 10 questions are summed to generate a total score. Higher scores represent a better outcome; the best score is 60, the worst score is 0. We used the change in PSEQ from the time of enrollment to 4 weeks after enrollment.
Time frame: at the time of enrollment and 4 weeks after enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Load Modification Education | Change in Pain Self-Efficacy Questionnaire (PSEQ) | 3.6 score on a scale | Standard Deviation 10.4 |
| Standard Exercise Education | Change in Pain Self-Efficacy Questionnaire (PSEQ) | 3.3 score on a scale | Standard Deviation 11.1 |
Secondary
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Bank v2.0 Physical Function
The Patient Reported Outcomes Measurement Information System Bank v2.0 Physical Function assesses self-reported physical function of respondents using computerized adaptive testing techniques. It uses responses to each item to calculate a T-score and it is recommended that scoring occur in REDCapTM or similar scoring service to calculate scores using response pattern scoring. The mean score for adults in the United States is 50 with a standard deviation of 10. Higher T-scores are associated with better function and lower T-scores are associated with worse physical function, and T-scores generally range from 20-80. We used the change in PROMIS-PF from the time of enrollment to 4 weeks after enrollment.
Time frame: at the time of enrollment and 4 weeks after enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Load Modification Education | Change in Patient Reported Outcomes Measurement Information System (PROMIS) Bank v2.0 Physical Function | 1.02 score on a scale | Standard Deviation 4.04 |
| Standard Exercise Education | Change in Patient Reported Outcomes Measurement Information System (PROMIS) Bank v2.0 Physical Function | 0.73 score on a scale | Standard Deviation 4.89 |
Secondary
Change in Victorian Institute of Sport Assessment for Greater Trochanteric Pain Syndrome (VISA-G)
The Victorian Institute of Sport Assessment for Greater Trochanteric Pain Syndrome is a 8-question survey about perceived hip pain and associated functional limitations during various daily activities. Question 1 asks respondents about their usual hip pain severity, scored from 0-10 (1-unit intervals), with 0 represent the worst pain. Questions 2-7 have 5 options that are scored 0, 2, 5, 7, or 10 points, with 0's representing extreme difficulty or inability and 10's representing no difficulty with the activity. Question 8 requires respondents to choose one subsection (A, B, or C) that best corresponds with how their hip pain affects their exercise; the minimum score is 0, the maximum is 30. To calculate the total score, scores from each question are summed. Higher total scores represent a better outcome; the best score is 100, the worst score is 0. We used the change in VISA-G from the time of enrollment to 4 weeks after enrollment.
Time frame: at the time of enrollment and 4 weeks after enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Load Modification Education | Change in Victorian Institute of Sport Assessment for Greater Trochanteric Pain Syndrome (VISA-G) | 7.7 score on a scale | Standard Deviation 13.1 |
| Standard Exercise Education | Change in Victorian Institute of Sport Assessment for Greater Trochanteric Pain Syndrome (VISA-G) | 1.1 score on a scale | Standard Deviation 11.9 |
Secondary
Patient Acceptable Symptomatic State Question
The Patient Acceptable Symptomatic State is a single question (yes/no response) asking respondents whether or not they are satisfied with their current state, considering all daily activities, their level of pain, and perceived functional impairment. Selecting 'Yes' would indicate the respondent is satisfied with their current state, selecting 'No' would indicate the respondent is not satisfied with their current state.
Time frame: 4 weeks after enrollment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Load Modification Education | Patient Acceptable Symptomatic State Question | Number indicating 'not satisfied' | 14 Participants |
| Load Modification Education | Patient Acceptable Symptomatic State Question | Number indicating 'satisified' | 8 Participants |
| Standard Exercise Education | Patient Acceptable Symptomatic State Question | Number indicating 'satisified' | 6 Participants |
| Standard Exercise Education | Patient Acceptable Symptomatic State Question | Number indicating 'not satisfied' | 19 Participants |
Secondary
Tegner Activity Level Scale
Tegner Activity Level Scale is a self-report scale of physical activity. The scale has 11 categorical options ranging from complete disability/inactivity (0) to national elite-level sports (11). The best score is 11, indicating elite-level activity participation.
Time frame: 4 weeks after enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Load Modification Education | Tegner Activity Level Scale | 3 score on a scale |
| Standard Exercise Education | Tegner Activity Level Scale | 3 score on a scale |