Hip InjuriesGLAMNCT03571971
Load Modification Versus Standard Exercise for Greater Trochanteric Pain Syndrome
A study testing Load modification education and Standard exercise education in people with Hip Injuries and Pain, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hip Injuries, Pain, Therapy/Rehabilitation
- What is being tested?
- Load modification education and Standard exercise education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2018to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- <!-- -->
- Any of the following treatments within the last 3 months:
- corticosteroid injection in the affected hip
- physical therapy or other skilled exercise intervention by a medical or rehabilitation professional
- Any of the following concomitant impairments or conditions:
- 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.
Show all 9Show fewer
- Groin pain as the primary hip pain complaint >/=2/10 most days of the week.
- <90 degrees of active hip and knee flexion bilaterally v. <0 degrees of active ankle dorsiflexion
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Jameson Crane Sports Medicine Institute
Columbus, Ohio, 43202
About this study
Official title: Load Modification Versus Standard Exercise to Inform Treatment for Individuals With Greater Trochanteric Pain Syndrome
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.
- Conditions
- Hip Injuries, Pain, Therapy/Rehabilitation
- Being tested
- Load modification education, Standard exercise education
- Medical subject headings
- Hip Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Load modification educationOther
Also called Load modification
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 educationOther
Also called Standard exercise
Standard exercise education includes exercises currently prescribed by physical therapists, like stretching and strengthening activities.
| Study group | Role | What they receive |
|---|---|---|
| Load modification education | Experimental | 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. Receives: Other: Load modification education |
| Standard exercise education | Active comparator | Standard exercise education includes exercises currently prescribed by physical therapists, like stretching and strengthening activities. Receives: Other: Standard exercise education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks after enrollment
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).
Measured: at the time of enrollment and 4 weeks after enrollment
Secondary outcomes (5)
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.
Measured: at the time of enrollment and 4 weeks after enrollment
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.
Measured: at the time of enrollment and 4 weeks after enrollment
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.
Measured: at the time of enrollment and 4 weeks after enrollment
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.
Measured: 4 weeks after enrollment
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.
Measured: 4 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start17 Jul 2018
- Primary completion14 Mar 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hip InjuriesStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Physical Therapy Research
- Responsible party
- Principal investigator, Stephanie Di Stasi, Ohio State University
- Investigators
- Stephanie Di Stasi, PhD, PT, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571971
- Sponsor's protocol ID
- 2017H0450
- Acronym
- GLAM
- Status last verified
- Oct 2024
- First submitted
- 18 Jun 2018
- Last updated
- 5 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this time, individual participant data (IPD) will be shared only with researchers listed on the funding associated with this project and the Institutional Review Board list of approved key personnel. Deidentified IPD will be made available upon request for purposes of manuscript review and submission. Deidentified IPD may be made available to individuals upon request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Load Modification Versus Standard Exercise to Inform Treatment for Individuals With Greater Trochanteric Pain Syndrome
- ClinicalTrials.gov ID
- NCT03571971
- Acronym / sponsor ID
- GLAM / 2017H0450
- Conditions
- Hip Injuries, Pain, Therapy/Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Foundation for Physical Therapy Research
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 28 Jun 2018 (actual)
- Results
- Posted 5 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Load modification education | Experimental | Other: Load modification educationLoad 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 | Active comparator | Other: Standard exercise educationStandard exercise education includes exercises currently prescribed by physical therapists, like stretching and strengthening activities. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- <!-- -->
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Load modification educationAlso: Load modificationLoad 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. | Other | Load modification education |
| Standard exercise educationAlso: Standard exerciseStandard exercise education includes exercises currently prescribed by physical therapists, like stretching and strengthening activities. | Other | Standard exercise education |
Primary outcome
Global Rating of Change
Time frame: 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
Time frame: 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).
5 secondary outcomes
Change in Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: at the time of enrollment and 4 weeks after enrollment
Change in Victorian Institute of Sport Assessment for Greater Trochanteric Pain Syndrome (VISA-G)
Time frame: at the time of enrollment and 4 weeks after enrollment
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Bank v2.0 Physical Function
Time frame: at the time of enrollment and 4 weeks after enrollment
Tegner Activity Level Scale
Time frame: 4 weeks after enrollment
Patient Acceptable Symptomatic State Question
Time frame: 4 weeks after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. At this time, individual participant data (IPD) will be shared only with researchers listed on the funding associated with this project and the Institutional Review Board list of approved key personnel. Deidentified IPD will be made available upon request for purposes of manuscript review and submission. Deidentified IPD may be made available to individuals upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Di Stasi, PhD, PT principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Load modification education and Standard exercise education in people with Hip Injuries and Pain, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Rating of Change (time frame: 4 weeks after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.