search
Back to results

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

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Deep dry needling
Muscle energy technique
Neck stability exercise
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Delta University for science and technology.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Group A

Group B

Group C

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in pain intensity from baseline to 4 weeks after.
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.
Change in function from baseline to 4 weeks after.
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.
Change in cervical range of motion (ROM) in sagittal, coronal and transverse planes from baseline to 4 weeks after.
AcuAngle® Inclinometer: (Baseline® AcuAngle Inclinometer; Elmsford, NY, U.S. PAT 2194335, 2-D Functions)
Change in pain threshold from baseline to 4 weeks after.
Pain Pressure Algometer: (BASELINE 22-POUND DOLORIMETER).

Secondary Outcome Measures

Full Information

First Posted
February 5, 2023
Last Updated
February 13, 2023
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT05730426
Brief Title
Comparison Between Deep Dry Needling and Muscle Energy Technique on Chronic Non-specific Neck Pain Patients.
Official Title
Deep Dry Needling Versus Muscle Energy Technique on Chronic Non-specific Neck Pain; a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Deep dry needling
Intervention Description
Method to decrease pain and improve function in musculoskeletal disorders.
Intervention Type
Procedure
Intervention Name(s)
Muscle energy technique
Other Intervention Name(s)
Post isometric relaxation
Intervention Description
Method to decrease pain and improve function in musculoskeletal disorders.
Intervention Type
Procedure
Intervention Name(s)
Neck stability exercise
Intervention Description
Method to decrease pain and improve function in musculoskeletal disorders.
Primary Outcome Measure Information:
Title
Change in pain intensity from baseline to 4 weeks after.
Description
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.
Time Frame
at baseline and after 4 weeks from the baseline.
Title
Change in function from baseline to 4 weeks after.
Description
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.
Time Frame
at baseline and after 4 weeks from the baseline.
Title
Change in cervical range of motion (ROM) in sagittal, coronal and transverse planes from baseline to 4 weeks after.
Description
AcuAngle® Inclinometer: (Baseline® AcuAngle Inclinometer; Elmsford, NY, U.S. PAT 2194335, 2-D Functions)
Time Frame
at baseline and after 4 weeks from the baseline.
Title
Change in pain threshold from baseline to 4 weeks after.
Description
Pain Pressure Algometer: (BASELINE 22-POUND DOLORIMETER).
Time Frame
at baseline and after 4 weeks from the baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haneen M. Ghalwash
Organizational Affiliation
Delta University for Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Delta University for science and technology.
City
Mansoura
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs