Comparison Between Deep Dry Needling and Muscle Energy Technique on Chronic Non-specific Neck Pain Patients.

February 13, 2023 updated by: Haneen Mohamed Abo El-enen Ghalwash, Cairo University

Deep Dry Needling Versus Muscle Energy Technique on Chronic Non-specific Neck Pain; a Randomized Controlled Trial.

The goal of this clinical trial is to compare between applying deep dry needling and muscle energy technique in chronic non-specific neck pain patients. Researchers will compare between deep dry needling group, muscle energy technique group and control group to see if there are change in pain, range of motion or function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Delta University for science and technology.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 and 40 years.
  2. Current neck pain.
  3. Presence of at least one or two trigger points .
  4. Patients are diagnosed and referred from orthopedist complaining from chronic neck pain for at least 12 weeks.
  5. No clinical treatment for neck pain within the past month.
  6. lacked a history of neck and shoulder myopathy, neuropathy, myelopathy and neck, torso and shoulder surgery.
  7. Patients with body mass index less than 30 kg/m2.

Exclusion Criteria:

  1. Patients outside the target range.
  2. Neck pain associated with vertigo.
  3. Osteoporosis.
  4. Diagnosed psychological disorders.
  5. Fibromyalgia syndrome.
  6. Vertebral fractures.
  7. Spinal stenosis.
  8. Tumors.
  9. Previous neck surgery.
  10. Red flags (night pain, severe muscle spasm, loss of involuntary weight, symptom mismatch).
  11. Physiotherapeutic treatment continued in the last 3 months. Any contraindications for deep dry needling such as anticoagulants, infections and bleeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Procedure: Deep dry needling
Method to decrease pain and improve function in musculoskeletal disorders.
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.
Procedure: Muscle energy technique
Method to decrease pain and improve function in musculoskeletal disorders.
Other Names:
  • Post isometric relaxation
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.
Procedure: Neck stability exercise
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)

  • A value of 0 denotes no pain, whereas a value of 1 to 3 indicates mild pain.
  • 4 to 6 denotes moderate pain.
  • 7 to 10 denotes intense pain.
at baseline and after 4 weeks from the baseline.
Change in function from baseline to 4 weeks after.
Time Frame: at baseline and after 4 weeks from the baseline.

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.

  • 0-4points (0-8%) no disability.
  • 5-14points (10 - 28%) mild disability.
  • 15-24points (30-48%) moderate disability.
  • 25-34points (50- 64%) severe disability.
  • 35-50points (70-100%) complete disability.
at baseline and after 4 weeks from the baseline.
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.
AcuAngle® Inclinometer: (Baseline® AcuAngle Inclinometer; Elmsford, NY, U.S. PAT 2194335, 2-D Functions)
at baseline and after 4 weeks from the baseline.
Change in pain threshold from baseline to 4 weeks after.
Time Frame: at baseline and after 4 weeks from the baseline.
Pain Pressure Algometer: (BASELINE 22-POUND DOLORIMETER).
at baseline and after 4 weeks from the baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

December 30, 2022

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

February 5, 2023

First Submitted That Met QC Criteria

February 13, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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