- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05730426
Comparison Between Deep Dry Needling and Muscle Energy Technique on Chronic Non-specific Neck Pain Patients.
Deep Dry Needling Versus Muscle Energy Technique on Chronic Non-specific Neck Pain; a Randomized Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Mansoura, Egypt
- Delta University for science and technology.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 and 40 years.
- Current neck pain.
- Presence of at least one or two trigger points .
- Patients are diagnosed and referred from orthopedist complaining from chronic neck pain for at least 12 weeks.
- No clinical treatment for neck pain within the past month.
- lacked a history of neck and shoulder myopathy, neuropathy, myelopathy and neck, torso and shoulder surgery.
- Patients with body mass index less than 30 kg/m2.
Exclusion Criteria:
- Patients outside the target range.
- Neck pain associated with vertigo.
- Osteoporosis.
- Diagnosed psychological disorders.
- Fibromyalgia syndrome.
- Vertebral fractures.
- Spinal stenosis.
- Tumors.
- Previous neck surgery.
- Red flags (night pain, severe muscle spasm, loss of involuntary weight, symptom mismatch).
- Physiotherapeutic treatment continued in the last 3 months. Any contraindications for deep dry needling such as anticoagulants, infections and bleeding.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A
In addition to Transcutaneous Electrical Nerve Stimulation (TENS) (typical,100 Hz, 20 mins), Infrared (7 mins), and Exercises (Cervical Stability Exercises through activation of deep neck flexors), patients received deep dry needling on active trigger points in selected muscles (upper trapezius, levator scapulae, and sternocleidomastoid ), 3 sessions/week, for 4 weeks period.
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Method to decrease pain and improve function in musculoskeletal disorders.
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|
Active Comparator: Group B
In addition to Transcutaneous Electrical Nerve Stimulation (TENS) (typical,100 Hz, 20 mins), Infrared (7 mins), and Exercises (Cervical Stability Exercises through activation of deep neck flexors), patients received muscle energy technique (post isometric relaxation) in selected muscles (upper trapezius, levator scapulae, and sternocleidomastoid ), 3 sessions/week, for 4 weeks period.
|
Method to decrease pain and improve function in musculoskeletal disorders.
Other Names:
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Placebo Comparator: Group C
Patients receive Transcutaneous Electrical Nerve Stimulation (TENS) (typical,100 Hz, 20 mins), Infrared (7 mins), and Exercises (Cervical Stability Exercises through activation of deep neck flexors) , 3 sessions/week, for 4 weeks period.
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Method to decrease pain and improve function in musculoskeletal disorders.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in pain intensity from baseline to 4 weeks after.
Time Frame: at baseline and after 4 weeks from the baseline.
|
Visual Analogue scale (VAS)
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at baseline and after 4 weeks from the baseline.
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Change in function from baseline to 4 weeks after.
Time Frame: at baseline and after 4 weeks from the baseline.
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The Neck Disability Index (NDI) The NDI questionnaire (scored out of 50) was used to measure the patient's perceived disability resulting from their neck pain. The score for each section was from 0 to 5, with 0 represented the highest level of function and 5 represented the lowest level of function. Total NDI scores were shown as a percentage. A high score corresponded to a higher degree of disability.
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at baseline and after 4 weeks from the baseline.
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Change in cervical range of motion (ROM) in sagittal, coronal and transverse planes from baseline to 4 weeks after.
Time Frame: at baseline and after 4 weeks from the baseline.
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AcuAngle® Inclinometer: (Baseline® AcuAngle Inclinometer; Elmsford, NY, U.S. PAT 2194335, 2-D Functions)
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at baseline and after 4 weeks from the baseline.
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Change in pain threshold from baseline to 4 weeks after.
Time Frame: at baseline and after 4 weeks from the baseline.
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Pain Pressure Algometer: (BASELINE 22-POUND DOLORIMETER).
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at baseline and after 4 weeks from the baseline.
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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
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003913
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
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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