Trial Outcomes & Findings for Load Modification Versus Standard Exercise for Greater Trochanteric Pain Syndrome (NCT NCT03571971)

NCT ID: NCT03571971

Last Updated: 2024-12-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

62 participants

Primary outcome timeframe

4 weeks after enrollment

Results posted on

2024-12-05

Participant Flow

One individual was enrolled and then withdrawn by the study team prior to randomization because they had a systemic condition that met study exclusion criteria.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verification process, and those participants who disclosed information that excluded them from study participation were withdrawn.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	31	30
Overall Study COMPLETED	23	25
Overall Study NOT COMPLETED	8	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	2	2
Overall Study Protocol Violation	2	3
Overall Study Withdrawal by Subject	2	0
Overall Study Incomplete primary outcome data	2	0

Baseline Characteristics

Load Modification Versus Standard Exercise for Greater Trochanteric Pain Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Load Modification Education n=31 Participants 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.	Standard Exercise Education n=30 Participants 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.	Total n=61 Participants Total of all reporting groups
Age, Continuous	54.4 years n=5 Participants	57.0 years n=7 Participants	55.9 years n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	27 Participants n=7 Participants	57 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	31 Participants n=5 Participants	30 Participants n=7 Participants	61 Participants n=5 Participants
Body Mass Index	29.2 kg/m^2 STANDARD_DEVIATION 9.2 • n=5 Participants	30.1 kg/m^2 STANDARD_DEVIATION 7.2 • n=7 Participants	29.7 kg/m^2 STANDARD_DEVIATION 8.2 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Load Modification Education n=23 Participants 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.	Standard Exercise Education n=25 Participants 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.
Global Rating of Change At least 'moderately better'	7 Participants	3 Participants
Global Rating of Change Were not at least 'moderately better'	16 Participants	21 Participants
Global Rating of Change Did not complete the question	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Load Modification Education n=23 Participants 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.	Standard Exercise Education n=25 Participants 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.
Change in Numeric Pain Rating Scale reported at least 2 point decrease in pain	10 Participants	10 Participants
Change in Numeric Pain Rating Scale did not report at least 2 point decrease in pain	13 Participants	15 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Load Modification Education n=20 Participants 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.	Standard Exercise Education n=24 Participants 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.
Change in Pain Self-Efficacy Questionnaire (PSEQ)	3.6 score on a scale Standard Deviation 10.4	3.3 score on a scale Standard Deviation 11.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Load Modification Education n=21 Participants 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.	Standard Exercise Education n=24 Participants 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.
Change in Victorian Institute of Sport Assessment for Greater Trochanteric Pain Syndrome (VISA-G)	7.7 score on a scale Standard Deviation 13.1	1.1 score on a scale Standard Deviation 11.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Load Modification Education n=21 Participants 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.	Standard Exercise Education n=25 Participants 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.
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Bank v2.0 Physical Function	1.02 score on a scale Standard Deviation 4.04	0.73 score on a scale Standard Deviation 4.89

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Load Modification Education n=21 Participants 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.	Standard Exercise Education n=24 Participants 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.
Tegner Activity Level Scale	3 score on a scale Interval 3.0 to 5.0	3 score on a scale Interval 3.0 to 5.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Load Modification Education n=22 Participants 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.	Standard Exercise Education n=25 Participants 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.
Patient Acceptable Symptomatic State Question Number indicating 'satisified'	8 Participants	6 Participants
Patient Acceptable Symptomatic State Question Number indicating 'not satisfied'	14 Participants	19 Participants

Adverse Events

Load Modification Education

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard Exercise Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Load Modification Education n=23 participants at risk 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.	Standard Exercise Education n=25 participants at risk 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.
Musculoskeletal and connective tissue disorders Musculoskeletal adverse event	4.3% 1/23 • Number of events 1 • Adverse event data were collected over the 4-week active intervention period during which time the participant received the exercise education (standard or load modification) and engaged in the 4-week home exercise program. We used adverse event and/or serious adverse event definitions as defined by clinicaltrials.gov. Additionally, we defined an 'Other (Not Including Serious) Adverse Event as either (1) acute onset, severe joint pain or sustain an acute injury during their participation in testing or physical therapy intervention or (2) two consecutive weeks where a participant reported either "moderately worse," "much worse,"or "very much worse" on their weekly Global Rating of Change question.	0.00% 0/25 • Adverse event data were collected over the 4-week active intervention period during which time the participant received the exercise education (standard or load modification) and engaged in the 4-week home exercise program. We used adverse event and/or serious adverse event definitions as defined by clinicaltrials.gov. Additionally, we defined an 'Other (Not Including Serious) Adverse Event as either (1) acute onset, severe joint pain or sustain an acute injury during their participation in testing or physical therapy intervention or (2) two consecutive weeks where a participant reported either "moderately worse," "much worse,"or "very much worse" on their weekly Global Rating of Change question.

Additional Information

Stephanie Di Stasi, Principal Investigator

The Ohio State University

Phone: 614-293-4220

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place