Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02842801 |
| Other study ID # |
18174 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
July 20, 2016 |
| Last updated |
July 22, 2016 |
| Start date |
August 2015 |
| Est. completion date |
August 2017 |
Study information
| Verified date |
July 2016 |
| Source |
Texas Woman's University |
| Contact |
Sharon Wangf-Price, PhD |
| Phone |
214-689-7715 |
| Email |
swang[@]twu.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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:
1. Numerical Pain Rating Scale (NPRS) with body charts
2. Lower Extremity Functional Scale
3. The Copenhagen Hip and Groin Outcome Score (HAGOS)
4. 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:
1. Functional tests: 3 functional tests will be assessed: deep squat, hurdle and inline
lunge.
2. 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.
3. 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.
4. 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
5. 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.
