NCT05730426

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

February 5, 2023

Last Update Submit

February 13, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    at baseline and after 4 weeks from the baseline.

  • 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.

    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.

    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.

    Pain Pressure Algometer: (BASELINE 22-POUND DOLORIMETER).

    at baseline and after 4 weeks from the baseline.

Study Arms (3)

Group A

ACTIVE COMPARATOR

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

Group B

ACTIVE COMPARATOR

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

Group C

PLACEBO COMPARATOR

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

Interventions

Method to decrease pain and improve function in musculoskeletal disorders.

Group A

Method to decrease pain and improve function in musculoskeletal disorders.

Also known as: Post isometric relaxation
Group B

Method to decrease pain and improve function in musculoskeletal disorders.

Group C

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Delta University for science and technology.

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Haneen M. Ghalwash

    Delta University for Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assisstat

Study Record Dates

First Submitted

February 5, 2023

First Posted

February 15, 2023

Study Start

August 1, 2022

Primary Completion

December 30, 2022

Study Completion

February 1, 2023

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations