Hip StrainNCT02842801
Hip Manipulation in Young Adults With Groin, Lateral Hip or Buttock Pain
A study testing Hip manipulation in people with Hip Strain, run by Texas Woman's University at 1 site in United States.
Trial summary
The purpose of the study is to identify the characteristics of young adults with pain in the groin, lateral hip or buttock who will benefit from manipulation of the hip. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Hip Strain
- What is being tested?
- Hip manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The eligible participants will be young adults of both genders between the ages of 18-40 who have complaints of groin, lateral hip and/or buttock pain.
Who cannot join
- Participants will be excluded from participating in this study if they have any of the following medical or surgical history. These factors may affect the results of the study:
- Impaired general health, e.g. fibromyalgia, chronic fatigue syndrome, cancer etc.
- Neurologic or neurovascular dysfunction
- History of peripheral vascular disease, diabetes or abdominal aneurysm
- History of hip joint pathology, such as slipped epiphysis, Legg Calve Perthes, significant congenital hip dysplasia, and hip dislocation,
- History of systemic disease affecting the musculoskeletal or neuromuscular systems, including inflammatory arthritides, connective tissue diseases, multiple sclerosis, muscular dystrophy, and cerebral vascular diseases
Show all 17Show fewer
- Known instabilities of hip or sacroiliac joint
- History of low back and lower extremity surgery, e.g. total hip replacement, total knee replacement, lumbar laminectomy.
- A diagnosed hip labral tests or clicking, catching, popping or hypermobility signs with hip labral tear tests
- Amputee of lower extremity
- Fracture hip or spine
- Infection in spine or lower extremities
- Hip ROM loss in all directions
- Pregnant or up to 12 weeks post-partum
- Bleeding or clotting disorders
- Osteoporosis
- Treated with hip manipulation in past 12 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Texas Woman's University
Dallas, Texas, 75235
Sharon Wang-Price, PhD, 214-689-7715, swang@twu.edu
About this study
Official title: Hip Manipulation in Young Adults With Complaints of Pain in the Groin, Lateral Hip or Buttock: Which Patients Will Have an Immediate Benefit?
The purpose of the study is to identify the characteristics of young adults with pain in the groin, lateral hip or buttock who will benefit from manipulation of the hip.
Read the detailed description
Unlike older adults with hip osteoarthritis, young adults with pain in the groin, lateral hip or buttock do not have general loss of ROM, but have a specific directional motion loss, such as hip flexion and internal rotation. Therefore, the most common manual therapy designed to gradually improve hip range of motions (ROM) for osteoarthritis, long axis distraction, may not be appropriate for treating young adults with hip pain. A manipulation technique, unrestrained femoral internal rotation (UFIR), was designed specifically for treating young adults' hip pain. Manipulation is a procedure that involves the use of a high- amplitude and low-velocity thrust at the mid or end range of a restricted joint for the purpose of improving range of motion (ROM) within the joint and the ability of the joint to tolerate loads.
Although clinicians routinely use this hip manipulation technique for treating young adults' hip pain with satisfying success, no study yet has been conducted to examine the effectiveness of this hip manipulation technique. The investigators are interested in identifying which young adults with pain in the groin, lateral hip or buttock would benefit from this hip manipulation.
Adverse effects of this manipulation have been reported to be none to mild. Mild soreness or muscle tenderness at the posterior greater trochanter region has been reported. In a preliminary study on the UFIR manipulation of 35 participants, 5 reported mild discomfort immediately after manipulation, but no participants reported adverse effects of a UFIR manipulation.
Purpose of the Study:
The purpose of the proposed study is to identify the characteristics of young adults with pain in the groin, lateral hip or buttock who will benefit from manipulation of the hip.
Research question:
What are the predictors for a positive outcome of hip manipulation on young adults with groin, lateral hip or buttock pain?
Procedures:
At the beginning of the study, all participants with groin/lateral hip/buttock pain will be informed of the risks, benefits and procedures of the study. Once the participants agree to participate, they will be asked to sign a written consent form approved by the TWU Institutional Review Board - Dallas. Once each participant signs the consent form, a number will be assigned to the participant and all forms to be used will be marked with this number. All data collection including the testing and treatment will be performed at the Texas Woman's University (TWU) - Dallas, Lab #8113, or in a private treatment room at the Physical Therapy \& Injury Specialist clinic, Englewood, CO. Each participant will come twice with 24-48 hours between visits.
1st Visit: On the first visit, all participants will be asked to fill out an intake form and a medical questionnaire to further determine the eligibility of each participant. Next, one of the investigators will perform a neurological exam, including dural tests, femoral nerve tests, deep tendon reflexes, key muscle tests and Babinski/Hoffman to rule out lumbar or neurologic involvement. If a participant is found to have a positive neurological test, the participant will be excluded from the study.
Outcome Measures and Special Questions:
Once the participant is determined to be eligible for the study, each participant will be asked to complete the following 4 questionnaires:
- Numerical Pain Rating Scale (NPRS) with body charts
- Lower Extremity Functional Scale
- The Copenhagen Hip and Groin Outcome Score (HAGOS)
- Special questions for functional activities.
The reliability and validity of the NPRS, LEFS and HAGOs have been shown to be reliable and valid. The special questions were used to describe the characteristics of the participants who are young adults with groin, lateral hip or buttock pain.
Physical Examination
A standard physical therapy examination specific to the hip will be performed by the investigator who will not perform the hip manipulation:
- Functional tests: 3 functional tests will be assessed: deep squat, hurdle and inline lunge.
- Palpation tests: 11 palpation tests will be examined. The surrounding bony landmark and soft tissue also will be palpated for tenderness and abnormality. To improve test accuracy, the investigators will video tape 2 palpation tests: single leg stand and single leg stance.
- Range of motion (ROM) measurements: 8 hip ROMs will be measured in supine and prone. A universal goniometer will be used to take all of hip ROMs. Two measurements will be taken for each motion, and the average of the two will be used for data analysis.
- Manual muscle strength tests: 8 hip manual muscle tests will be performed in sitting, supine, sidelying and prone positions:
- Sitting: flexion
- Supine: flexion, internal rotation and external rotation
- Sidelying: abduction
- Prone: extension, internal rotation and internal rotation
- Provocation tests of lumbar, sacroiliac and hip joints.
Intervention:
The other investigator, a licensed physical therapist and different from the one who performed physical examination as described above, will perform the intervention technique, hip manipulation UFIR. During the manipulation, the participant will be asked to lie on the unaffected side with the affected side up, their hip(s) flexed to approximately 30 degrees, and knees flexed to approximately 50-70 degrees. Pillows will be place between the participant's knees as needed for comfort. The investigator will stabilize the anterior inferior iliac spine (ASIS) and ilium with the fingers of one hand and place the thumb on the posterior aspect of the greater trochanter of the involved hip. The participant will be asked for verbal approval prior to receiving the manipulation. The manipulation will be performed with the investigator's non-stabilizing hand, by thrusting the greater trochanter anteriorly with an internal rotation moment.
The manipulation will be performed on the involved side. If the participant or the investigator feels a cavitation or shift in the hip joint after the first manipulation, the intervention will be considered complete. If no cavitation/shift is heard or felt by the participant or the investigator after the first manipulation, the investigator will repeat the manipulation up to a maximum of three times. The manipulation will be performed by either of two physical therapists who have specialized in manual therapy, and have been certified after participating in an extensive clinical education and examination process.
Post Intervention After the hip manipulation intervention, the investigator will advise the participant to continue any regular activity but to not perform new activities. In addition, the participant will be asked to fill out the NPRS with body charts (Appendix E) and the Global Rating of Change (GROC) Scale (Appendix M).16 The participant will reminded of the second visit day and appointment time within 24-48 hours.
2nd Visit During the 2nd visit, the same investigator who has evaluated the participant on his/her 1st visit will perform the same physical exam as described on the first visit, with the same measurement or reporting details. Following this physical exam, the participant will be asked to fill out the NPRS with body charts, LEFS, HAGOS and GROC forms. There will be no further treatment for the purpose of the study.
Data Analysis The participants will be dichotomized into two groups based on their response to the hip manipulation: successful or non-successful. Success will be defined as 2 points or greater change in the NPRS or 4 points or greater change in the GROC. These criteria will be used as reference standards to dichotomize the participants for all variables collected from patient's history, self-reported questionnaires and physical exam. Regression analysis will be used to examine significant predictors/characteristics for a successful outcome of hip manipulation on young adults with groin, lateral hip or buttock pain.
- Conditions
- Hip Strain
- Being tested
- Hip manipulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip manipulationOther
High-amplitude and low-velocity thrust mobilization
| Study group | Role | What they receive |
|---|---|---|
| Hip Manipulation | Other | Hip manipulation: high velocity low amplitude thrust mobilization Receives: Other: Hip manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Rating of Change (GROC) Scale
24-48 hours
Measured: Short-term
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startAug 2015
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip StrainStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Wang-Price, Texas Woman's University
- Investigators
- Sharon Wang-Price, PhD, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842801
- Sponsor's protocol ID
- 18174
- Status last verified
- Jul 2016
- First submitted
- 20 Jul 2016
- Last updated
- 25 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hip Manipulation in Young Adults With Complaints of Pain in the Groin, Lateral Hip or Buttock: Which Patients Will Have an Immediate Benefit?
- ClinicalTrials.gov ID
- NCT02842801
- Acronym / sponsor ID
- 18174
- Conditions
- Hip Strain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 25 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to identify the characteristics of young adults with pain in the groin, lateral hip or buttock who will benefit from manipulation of the hip.
Detailed description
Unlike older adults with hip osteoarthritis, young adults with pain in the groin, lateral hip or buttock do not have general loss of ROM, but have a specific directional motion loss, such as hip flexion and internal rotation. Therefore, the most common manual therapy designed to gradually improve hip range of motions (ROM) for osteoarthritis, long axis distraction, may not be appropriate for treating young adults with hip pain. A manipulation technique, unrestrained femoral internal rotation (UFIR), was designed specifically for treating young adults' hip pain. Manipulation is a procedure that involves the use of a high- amplitude and low-velocity thrust at the mid or end range of a restricted joint for the purpose of improving range of motion (ROM) within the joint and the ability of the joint to tolerate loads.
Although clinicians routinely use this hip manipulation technique for treating young adults' hip pain with satisfying success, no study yet has been conducted to examine the effectiveness of this hip manipulation technique. The investigators are interested in identifying which young adults with pain in the groin, lateral hip or buttock would benefit from this hip manipulation.
Adverse effects of this manipulation have been reported to be none to mild. Mild soreness or muscle tenderness at the posterior greater trochanter region has been reported. In a preliminary study on the UFIR manipulation of 35 participants, 5 reported mild discomfort immediately after manipulation, but no participants reported adverse effects of a UFIR manipulation.
Purpose of the Study:
The purpose of the proposed study is to identify the characteristics of young adults with pain in the groin, lateral hip or buttock who will benefit from manipulation of the hip.
Research question:
What are the predictors for a positive outcome of hip manipulation on young adults with groin, lateral hip or buttock pain?
Procedures:
At the beginning of the study, all participants with groin/lateral hip/buttock pain will be informed of the risks, benefits and procedures of the study. Once the participants agree to participate, they will be asked to sign a written consent form approved by the TWU Institutional Review Board - Dallas. Once each participant signs the consent form, a number will be assigned to the participant and all forms to be used will be marked with this number. All data collection including the testing and treatment will be performed at the Texas Woman's University (TWU) - Dallas, Lab #8113, or in a private treatment room at the Physical Therapy \& Injury Specialist clinic, Englewood, CO. Each participant will come twice with 24-48 hours between visits.
1st Visit: On the first visit, all participants will be asked to fill out an intake form and a medical questionnaire to further determine the eligibility of each participant. Next, one of the investigators will perform a neurological exam, including dural tests, femoral nerve tests, deep tendon reflexes, key muscle tests and Babinski/Hoffman to rule out lumbar or neurologic involvement. If a participant is found to have a positive neurological test, the participant will be excluded from the study.
Outcome Measures and Special Questions:
Once the participant is determined to be eligible for the study, each participant will be asked to complete the following 4 questionnaires:
- Numerical Pain Rating Scale (NPRS) with body charts
- Lower Extremity Functional Scale
- The Copenhagen Hip and Groin Outcome Score (HAGOS)
- Special questions for functional activities.
The reliability and validity of the NPRS, LEFS and HAGOs have been shown to be reliable and valid. The special questions were used to describe the characteristics of the participants who are young adults with groin, lateral hip or buttock pain.
Physical Examination
A standard physical therapy examination specific to the hip will be performed by the investigator who will not perform the hip manipulation:
- Functional tests: 3 functional tests will be assessed: deep squat, hurdle and inline lunge.
- Palpation tests: 11 palpation tests will be examined. The surrounding bony landmark and soft tissue also will be palpated for tenderness and abnormality. To improve test accuracy, the investigators will video tape 2 palpation tests: single leg stand and single leg stance.
- Range of motion (ROM) measurements: 8 hip ROMs will be measured in supine and prone. A universal goniometer will be used to take all of hip ROMs. Two measurements will be taken for each motion, and the average of the two will be used for data analysis.
- Manual muscle strength tests: 8 hip manual muscle tests will be performed in sitting, supine, sidelying and prone positions:
- Sitting: flexion
- Supine: flexion, internal rotation and external rotation
- Sidelying: abduction
- Prone: extension, internal rotation and internal rotation
- Provocation tests of lumbar, sacroiliac and hip joints.
Intervention:
The other investigator, a licensed physical therapist and different from the one who performed physical examination as described above, will perform the intervention technique, hip manipulation UFIR. During the manipulation, the participant will be asked to lie on the unaffected side with the affected side up, their hip(s) flexed to approximately 30 degrees, and knees flexed to approximately 50-70 degrees. Pillows will be place between the participant's knees as needed for comfort. The investigator will stabilize the anterior inferior iliac spine (ASIS) and ilium with the fingers of one hand and place the thumb on the posterior aspect of the greater trochanter of the involved hip. The participant will be asked for verbal approval prior to receiving the manipulation. The manipulation will be performed with the investigator's non-stabilizing hand, by thrusting the greater trochanter anteriorly with an internal rotation moment.
The manipulation will be performed on the involved side. If the participant or the investigator feels a cavitation or shift in the hip joint after the first manipulation, the intervention will be considered complete. If no cavitation/shift is heard or felt by the participant or the investigator after the first manipulation, the investigator will repeat the manipulation up to a maximum of three times. The manipulation will be performed by either of two physical therapists who have specialized in manual therapy, and have been certified after participating in an extensive clinical education and examination process.
Post Intervention After the hip manipulation intervention, the investigator will advise the participant to continue any regular activity but to not perform new activities. In addition, the participant will be asked to fill out the NPRS with body charts (Appendix E) and the Global Rating of Change (GROC) Scale (Appendix M).16 The participant will reminded of the second visit day and appointment time within 24-48 hours.
2nd Visit During the 2nd visit, the same investigator who has evaluated the participant on his/her 1st visit will perform the same physical exam as described on the first visit, with the same measurement or reporting details. Following this physical exam, the participant will be asked to fill out the NPRS with body charts, LEFS, HAGOS and GROC forms. There will be no further treatment for the purpose of the study.
Data Analysis The participants will be dichotomized into two groups based on their response to the hip manipulation: successful or non-successful. Success will be defined as 2 points or greater change in the NPRS or 4 points or greater change in the GROC. These criteria will be used as reference standards to dichotomize the participants for all variables collected from patient's history, self-reported questionnaires and physical exam. Regression analysis will be used to examine significant predictors/characteristics for a successful outcome of hip manipulation on young adults with groin, lateral hip or buttock pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hip Manipulation | Other | Other: Hip manipulationHip manipulation: high velocity low amplitude thrust mobilization |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The eligible participants will be young adults of both genders between the ages of 18-40 who have complaints of groin, lateral hip and/or buttock pain.
Key exclusion criteria (17 listed)
- Participants will be excluded from participating in this study if they have any of the following medical or surgical history. These factors may affect the results of the study:
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 |
|---|---|---|
| Hip manipulationHigh-amplitude and low-velocity thrust mobilization | Other | Hip Manipulation |
Primary outcome
Global Rating of Change (GROC) Scale
Time frame: Short-term
24-48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
- Individual participant dataSharing planned: No
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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.
Sharon Wang-Price, PhD principal investigator
Texas Woman's 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 Hip manipulation in people with Hip Strain, run by Texas Woman's 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 1 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 25 Jul 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sharon Wangf-Price, PhD (214-689-7715, swang@twu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Rating of Change (GROC) Scale (time frame: Short-term). 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 25 Jul 2016.