NCT06707870

Brief Summary

To compare the effects of Cervical Retraction Exercise and Facet Oscillatory Mobilization in chronic Mechanical Neck pain. To compare the effects of Cervical Retraction Exercise and Facet Oscillatory Mobilization in chronic Mechanical Neck pain at improving Neck Disability. To compare the effects of Cervical Retraction Exercise and Facet Oscillatory Mobilization in chronic Mechanical Neck pain at Improving Range of Motion The study design used for this literature would be Randomized Control Trial This study would include total 32 participants which would be divided into two groups, 16 each.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2024

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

November 25, 2024

Last Update Submit

November 25, 2024

Conditions

Keywords

Chronic neck painFacet oscillatory mobilizationCervical retraction exercise

Outcome Measures

Primary Outcomes (3)

  • Neck disability index

    This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life. Score: /50 Transform to percentage score x 100 = %points. It has 7 items for daily living, 2 for pain and 1 for concentration. Each item is rated from 0 to 5. Total score is presented in percentage. Higher score tells greater disability while 0 means no disability. Total score is 50. In cervical radiculopathy patients it has moderate test retest reliability ICC= 0.68 .The NDI has a fair to moderate test-retest reliability in patients with mechanical neck pain but also for patients with cervical radiculopathy. The NDI has a good construct validity.

    6 weeks

  • Numerical pain rating scale

    The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") High test-retest reliability has been observed in both literate and illiterate patients with rheumatoid arthritis (r = 0.96 and 0.95, respectively) before and after medical consultation.

    6 weeks

  • Inclinometer

    An inclinometer is a device used to measure angles. It is commonly used in physiotherapy to measure the range of motion (ROM) of joints and very similar to a goniometer. The digital inclinometer demonstrated excellent reliability (ICC=0.75-0.86), except for the right lateral flexion (ICC=0.74) and left rotation (ICC=0.72).

    6 weeks

Study Arms (2)

Cervical retraction exercise

EXPERIMENTAL

Cervical retraction exercise

Other: Cervical retraction exercise

Facet oscillatory mobilization

EXPERIMENTAL

Facet oscillatory mobilization

Other: Facet oscillatory mobilization

Interventions

Neck retraction exercises are performed on patients either in sitting or standing in an upright position while pushing their chin backward and simultaneously raising their head within the pain-free range (3 seconds hold)of 10 repetitions in each session at sitting position. Conventional treatment (TENS (2 to 10 Hz),10 mints, Heating pad, stretching of tight muscles Trapezius and SCM)should be included. The patients will received 20-30-minute sessions on 3 alternate days for two consecutive weeks, making it a total of 6 sessions. Patients were advised to revisit after 4 weeks (1 month from the baseline) for follow-up.

Cervical retraction exercise

Facet joint oscillatory mobilization on the cervical spine C2-C7(6 to 10 repetitions in each session) in the sitting position. Conventional treatment (TENS (2 to 10 Hz) 10 mints, Heating pad, stretching of tight muscles Trapezius and SCM) should be included. The patients will received 20-30-minute sessions on 3 alternate days for two consecutive weeks, making it a total of 6 sessions. Patients were advised to revisit after 4 weeks (1 month from the baseline) for follow-up.

Facet oscillatory mobilization

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants falling in this category would be recruited into the study.
  • Participants were patients with a complaint of Chronic Mechanical neck pain (\> 6 weeks).
  • Neck Disability Index (NDI) score \> 16%
  • Age between 35-50 years, Both Male and Female
  • NPRS score \>3-6.
  • Recurrent neck pain aggravated at least once in the month.
  • Painful Cervical ROM (Flexion \<80 Extension\<70 rotation\<90 to both sides and lateral flexion \<35 degree.
  • Spurling test negative
  • Patients willing to participates in the study after filling the consent form.
  • Upper Limb Nerve tension test (Median, Radial, and Ulnar negative).

You may not qualify if:

  • Participant failing to fall in this category would be excluded of the study.
  • Cervical radiculopathy
  • Cervical canal stenosis
  • Severe neurological disorder
  • Previous cervical surgery
  • Recent history of fall/trauma to the cervical spine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khyber Teaching hospital

Peshawar, KPK, 25000, Pakistan

RECRUITING

Related Publications (2)

  • Alansari SM, Youssef EF, Shanb AA. Efficacy of manual therapy on psychological status and pain in patients with neck pain. A randomized clinical trial. Saudi Med J. 2021 Jan;42(1):82-90. doi: 10.15537/smj.2021.1.25589.

    PMID: 33399175BACKGROUND
  • Phadke A, Bedekar N, Shyam A, Sancheti P. Effect of muscle energy technique and static stretching on pain and functional disability in patients with mechanical neck pain: A randomized controlled trial. Hong Kong Physiother J. 2016 Apr 14;35:5-11. doi: 10.1016/j.hkpj.2015.12.002. eCollection 2016 Dec.

    PMID: 30931028BACKGROUND

Study Officials

  • Faheem Ullah Jan, MS-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Aman Ullah Nazir, PhD*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2024

First Posted

November 27, 2024

Study Start

May 1, 2024

Primary Completion

December 13, 2024

Study Completion

December 13, 2024

Last Updated

November 27, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations