NCT07477145

Brief Summary

To investigate the effect of body mind exercise and specific neck exercises in chronic mechanical neck pain on neck pain severity, functional disability, neck flexion range of motion, isometric neck muscle strength and quality of life.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

March 25, 2026

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Completed
Last Updated

March 17, 2026

Status Verified

February 1, 2026

Enrollment Period

5 days

First QC Date

February 28, 2026

Last Update Submit

March 13, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • Pain Intensity

    Numeric Pain Rating Scale (NPRS, Arabic version) 0-10 scale; validated for Arabic-speaking populations (Alghadir et al., 2016)

    (pre-intervention) and after 6 weeks (post-intervention).

  • Quality of Life Measured by RAND-36 Health Survey

    Measures physical, emotional, and social functioning .

    (pre-intervention) and after 6 weeks (post-intervention).

  • Functional Disability

    Neck Disability Index (NDI, Arabic version) 10-item questionnaire.

    (pre-intervention) and after 6 weeks (post-intervention).

  • Cervical ROM

    CROM device. Measures flexion, extension, lateral flexion, rotation; 3 repetitions per movement (Kiatkulanusorn et al., 2023).

    (pre-intervention) and after 6 weeks (post-intervention).

  • Isometric Neck Strength

    Handheld dynamometer (HHD) Flexion (forehead), Extension (occiput), 3 maximal contractions of 5 sec each, average recorded (Ghamkhar et al., 2011)

    (pre-intervention) and after 6 weeks (post-intervention).

Study Arms (4)

Group A: Conventional physical therapy group (Control group)

EXPERIMENTAL

Group A will receive conventional therapy which includes: heat therapy (infrared) for 10 minutes, massage therapy 10 min, stretching of neck (Scalene, SCM, UFT, Levator scapulae) and pectoral muscles 20 min.

Behavioral: Conventional physical therapy group.

Group B: Body mind exercises group (mindful aerobic exercises)

EXPERIMENTAL

Group B will receive conventional physical therapy (infrared, massage, and neck stretching) in addition to Body mind exercises (mindful aerobic exercises). The aerobic exercise will be performed at an intensity of at least 60% of maximal oxygen consumption (VOâ‚‚ max) to effectively improve cardiorespiratory fitness. The program will include treadmill walking 30 minutes.

Behavioral: Conventional physical therapy group.Behavioral: Body mind exercises group (mindful aerobic exercises)

Group C: specific neck exercise group

EXPERIMENTAL

Group C will receive conventional therapy in addition to specific neck exercises. Specific exercises will include: cervical and scapular stabilization exercises.

Behavioral: Conventional physical therapy group.Behavioral: specific neck exercise group

Group D : Combined exercise group.

EXPERIMENTAL

Group D will receive conventional therapy in addition to mindful aerobic exercises, cervical and scapular stabilization.

Behavioral: Conventional physical therapy group.Behavioral: Body mind exercises group (mindful aerobic exercises)Behavioral: specific neck exercise groupBehavioral: Combined exercise group.

Interventions

conventional therapy which includes: heat therapy (infrared) for 10 minutes, massage therapy 10 min, stretching of neck (Scalene, SCM, UFT, Levator scapulae) and pectoral muscles 20 min.

Group A: Conventional physical therapy group (Control group)Group B: Body mind exercises group (mindful aerobic exercises)Group C: specific neck exercise groupGroup D : Combined exercise group.

Group B will receive conventional physical therapy (infrared, massage, and neck stretching) in addition to Body mind exercises (mindful aerobic exercises). The aerobic exercise will be performed at an intensity of at least 60% of maximal oxygen consumption (VOâ‚‚ max) to effectively improve cardiorespiratory fitness. The program will include treadmill walking 30 minutes.

Group B: Body mind exercises group (mindful aerobic exercises)Group D : Combined exercise group.

Group C will receive conventional therapy in addition to specific neck exercises. Specific exercises will include: cervical and scapular stabilization exercises.

Group C: specific neck exercise groupGroup D : Combined exercise group.

Group D will receive conventional therapy in addition to mindful aerobic exercises, cervical and scapular stabilization exercises.

Group D : Combined exercise group.

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged between 50-65 years
  • Diagnosis of chronic mechanical neck pain (pain duration ≥ 3 months)
  • Pain intensity of at least 3/10 on the NPRS

You may not qualify if:

  • History of cervical surgery
  • Specific neck conditions (fractures, neoplasm, infection)
  • Pregnancy
  • Severe cardiopulmonary disease or other systemic illness affecting participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculity of Physical Therapy in Cairo University

Cairo, 12613, Egypt

Location

Related Publications (45)

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    RESULT
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    RESULT
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Related Links

Study Officials

  • RAMY I KOMIR, MSc

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

RAMY I KOMIR, MSc

CONTACT

RAMY I KOMIR, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the exercise interventions, participants and treating therapists cannot be blinded. However, the outcome assessor responsible for measuring pain, cervical range of motion, and neck muscle strength will be blinded to group allocation to reduce measurement bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is a randomized, parallel-group, controlled clinical trial with four intervention arms. Participants with chronic mechanical neck pain will be randomly allocated into one of four groups receiving different combinations of body-mind exercises, specific neck exercises, and conventional physical therapy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 28, 2026

First Posted

March 17, 2026

Study Start

March 25, 2026

Primary Completion

March 30, 2026

Study Completion

May 31, 2026

Last Updated

March 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

sensitive patient data.

Available IPD Datasets

Study Protocol (P.T.REC/012/006226)Access

Locations