- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07703332
Elongation Longitudinal Decoaptation Ostéo-Articulaire Versus Active Isolated Stretching on Median Nerve Mobility and Pain in Patient With Upper Limb Overuse Syndrome
Upper-limb overuse syndrome (ULOS) often arises from repetitive loading, altering cervical biomechanics and increased median-nerve mechano sensitivity. Elongation longitudinal decoaptation ostéo-articulaire (ELDOA) at C5-C6 improves segmental decompression and neural sliding, while Active isolated stretching (AIS) enhances soft tissue elasticity and neuro dynamic glide.
Currently no direct comparison exists between these two methods in literature. Study aims to compare ELDOA (C5-C6 specific) and AIS in patients with ULOS for checking effects on median nerve mobility and pain. This research will be conducted as a randomized clinical trial involving 84 participants (42 in each group). Adults aged 20-50 years with diagnosis of ULOS, symptom duration 3- months (12 weeks) will be included in the study. While Neurological or rheumatologic conditions, recent corticosteroid injections, recent cervical or major upper limb surgery, and ongoing neural mobilization-focused physical therapy are among the exclusions. After meeting the inclusion and exclusion criteria and obtaining written and verbal consent from the participants. Participants will be randomly assigned to either the AIS or ELDOA groups and will receive 3 sessions per week for 3 weeks with baseline hot pack. Group A will perform diaphragmatic breathing with ELDOA targeting C5-C6, whereas Group B will engage in AIS on muscles that cause median-nerve tension. Pain intensity, upper limb function and median nerve mobility are outcome measures that will be assessed using tools NPRS, QuickDASH and ULTT1. Data will be analyzed using the 2024 SPSS.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr. Rubina Zulfqar
- Phone Number: +923414291664
- Email: drubinazulfqar355@gmail.com
Study Locations
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Punjab Province
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Faisalabad, Punjab Province, Pakistan, 38000
- Recruiting
- Dr . Rubina Zulfqar
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All adult age group (20-50 years) patients with clinical symptoms and signs of upper limb overuse syndrome with median nerve were included in the study (Latif et al., 2022).
- Participants included individuals engaged in repetitive upper-limb activities, such as office workers, manual laborers, athletes and students, who demonstrated median nerve involvement associated with repetitive task performance (Descatha et al., 2017).
- Persistent pain in the upper limb, pain intensity score from 3-7 on the Numeric pain rating scale (NPRS), discomfort and functional limitations in daily activities, occupational tasks or recreational activities were deemed to be indications of eligibility for participation in the study (Hawker et al., 2011).
- Participants with persistent nature symptoms (3 months or more than 3 months) are included in the study to secure homogenous study population (Nicholas et al., 2019).
- Willing to give their informed consent and take part.
Exclusion Criteria:
- Trauma, surgery, fracture or dislocation of the upper limb in the last six months or less were excluded to minimize the possibility of studying the acute tissue healing on the results of this study (Cools et al., 2021).
- Other neurological conditions (e.g., peripheral or central nervous system disorders, systemic neuropathies, cervical radiculopathy, or other neurological disorders) were excluded for participation (Padua et al., 2020).
- The potential effect of rheumatologic or inflammatory musculoskeletal disorders (rheumatoid arthritis, lupus, or other systemic inflammatory diseases) on pain and functional status was also a reason for exclusion (Smolen et al., 2020).
- No corticosteroid uses or prior physical therapy within 3 months to reduce the potentially confounding effect of prior therapeutic interventions on study outcomes (Kolasinski et al., 2020).
- Participants were excluded from the study if they had any contraindications to manual therapy treatment that could affect the safety of the intervention (e.g., vascular, severe osteoporosis, malignancy, acute infection, other conditions) (Puentedura et al., 2012).
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 |
|---|---|
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Experimental: Elongation longitudinal decoaptation ostéo-articulaire (ELDOA)
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Common baseline treatment (both Groups) Prior to their designated intervention, both groups will receive the following standardized baseline treatment:
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Experimental: Active isolated stretching (AIS)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: 3 weeks
|
Pain intensity will be measured by using numeric pain rating scale
|
3 weeks
|
|
Functional status/ Disability
Time Frame: 3 weeks
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Functional status/ Disability will be measured by using QuickDASH questionnaire, The lower the Quick DASH score, the better the upper limb function and fewer the activity limitations.
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3 weeks
|
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Nerve mobility
Time Frame: 3 weeks
|
Nerve mobility will be measured by using Upper Limb Tension Test (ULTT1), Better responses in the ULTT1 suggest better median nerve mobility and lower neural tension.
|
3 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- Tuf/EIRB/170/26
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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