- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06655987
Hip Manipulation for Improved Strength in Patients With Hip Pain
Effects of Unrestrained Femoral Internal Rotation Manipulation on Hip External Rotation Strength in Individuals With Nonspecific Hip Pain: A One-Week Follow-Up Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background and Rationale
Hip pain is a prevalent and debilitating condition affecting adults of all ages and activity levels, with significant impact on daily function. In athletes, the rates of hip injuries are particularly high. The heterogeneity of nonspecific hip pain, coupled with limited research on accurate diagnosis and treatment, poses challenges for physical therapists.
This study focuses on the potential of joint manipulation, particularly the Unrestrained Femoral Internal Rotation (UFIR) technique, to improve hip external rotation strength in individuals with nonspecific hip pain and weakness. While strength training is commonly used to address hip weakness, there's a lack of research on alternative approaches like joint manipulation. This research seeks to bridge this gap and explore the potential benefits of UFIR manipulation in enhancing hip function and reducing pain.
Research Procedures
Design: Prospective, randomized, controlled trial Setting: SKYE Physiotherapy, Columbia, MD Sample: 24 adults (18-55 years) with nonspecific hip pain and ipsilateral hip external rotation weakness Intervention: Experimental group receives UFIR manipulation, control group receives sham manipulation Outcome Measures: Bilateral hip external rotation strength assessed by manual muscle testing (MMT) and hand-held dynamometer (HHD) at baseline, immediately post-intervention, and 1-week follow-up.
Data Analysis: Descriptive statistics, Friedman test, Kruskal-Wallis test, ANOVA, and repeated measures ANOVA will be used to analyze data.
Study Procedures
Recruitment: Participants will be recruited through flyers and social media platforms.
Screening and Enrollment: Eligible participants will complete an electronic health screening form and provide informed consent.
Randomization: Participants will be randomly assigned to either the experimental or control group.
Intervention: The examiner will administer UFIR manipulation to the experimental group and sham manipulation to the control group.
Assessments: Hip external rotation strength will be measured using MMT and HHD at baseline, immediately post-intervention, and at 1-week follow-up.
Data Analysis: Statistical analysis will be performed to assess changes in hip external rotation strength within and between groups.
Internal Validity and Generalizability
The study acknowledges potential threats to internal validity, including testing effects, instrumental bias, and experimenter bias. Measures to mitigate these threats include standardized techniques, a one-week interval between assessments, and randomization. The study aims to recruit a diverse sample from Howard County, MD, to enhance external validity and generalizability of findings.
Conclusion
This study aims to contribute to the understanding of the potential benefits of joint manipulation, specifically UFIR, in improving hip external rotation strength and function in individuals with nonspecific hip pain and weakness. The findings may inform clinical practice and provide alternative treatment options for this patient population.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Columbia, Maryland, United States, 21044
- SKYE Physiotherapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- individuals who meet the following inclusion criteria will be eligible to participate in this study: 1) nonspecific hip pain, 2) ipsilateral hip external rotation weakness (at or below 3+) based on the MMT test
Exclusion Criteria:
- individuals who meet any of the following exclusion criteria will not be eligible to participate in this study: 1) do not speak English, 2) have an impaired cognition and are unable to follow multi-step commands, 3) require an assistive device for standing balance, 4) have complaints of intractable (intolerable) pain, 5) have a history of hip dislocation or total hip replacement, 6) have a history of hip fracture or arthroscopy in the past 6 months, 7) have a history of lumbar spine fracture or surgery (e.g., lumbar discectomy and fusion) in the past 6 months, 8) present with neurological condition (i.e., stroke, Parkinson's disease, or lumbar radiculopathy), 9) known congenital hip dysplasia/adolescent hip disease, and 10) known osteoporosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
Participants receiving the Unrestrained Femoral Internal Rotation (UFIR) manipulation.
|
This is the primary intervention applied to the experimental group.
It involves a high-velocity, low-amplitude thrust at the greater trochanter of the affected hip, intended to improve joint mobility and potentially address neuromuscular dysfunction contributing to hip pain and weakness.
|
|
Placebo Comparator: Control Group
Participants receiving a sham manipulation (gentle hand placement)
|
This serves as the control intervention.
It involves gentle hand placement over the affected hip's external rotators for a brief duration.
This is intended to mimic the physical contact of the UFIR manipulation without actually delivering the therapeutic thrust.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in hip external rotation strength (measured in pounds using a hand-held dynamometer)
Time Frame: Baseline (pre-intervention), immediately post-intervention, and one-week follow-up
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Baseline (pre-intervention), immediately post-intervention, and one-week follow-up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB 24-062
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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