NCT05834114

Brief Summary

The study will be randomized clinical trial. Total 40 subjects will be assigned randomly by using non probability convenient into two groups. Group A will be given McKenzie protocol, with conventional physiotherapy treatment while Group B is Rhythmic stabilization group who will receive rhythmic stabilization, with conventional physiotherapy. After confirmation of diagnosis with medical history and physical examination numeric pain rating scale (NPRS) and Neck disability index (NDI) would be used as an outcome measure tools for pain and disability respectively. Measure will be taken by goniometer. After data collection from defined study setting,data will be entered and analyzed at Riphah International University, Lahore.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

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

February 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

April 18, 2023

Last Update Submit

September 22, 2023

Conditions

Keywords

Mckenzie protocolRhythmic Stabilization technique

Outcome Measures

Primary Outcomes (2)

  • Numeric pain rating scale for pain

    NPRS is based on 11-point numerical rating scale for determining pain intensity, 0(no pain) to 10(worst pain imaginable) pain intensity. On average over the past 2 day how bad has your pain been.

    3 weeks

  • Neck disability index

    The Neck Disability Index (NDI) (modification of the Oswestry Low Back Pain Disability Index). (0-8%) no disability, ( 10 - 28%) mild disability, (30-48% ) moderate disability, (50- 64%) severe disability, (70-100%) complete disability

    3 weeks

Secondary Outcomes (1)

  • The Universal goniometer

    3 weeks

Study Arms (2)

McKenzie protocol

EXPERIMENTAL

In this group, 20 participants will be included. the interventions will be given for 15 mint. The exercises then repeated five or six times in a Session. the session will be of 45 mins, 3 session per week.

Other: Mckenzie protocol

Rhythmic stabilization technique

ACTIVE COMPARATOR

In this group, 20 participants will be included. Rhythmic Stabilization with traditional physical therapy will be given for 3 sessions of 45 minutes a week, over a period of 10 weeks.

Other: Rhythmic Stabilization technique

Interventions

In this group 20 participants will receive McKenzie protocol with conventional physical therapy. Participants will be asked to sit to treat extension deficit. The participant will be in a comfortable sitting position with a proper back support. Head is kept in forward facing without any up and done movement (10 to 15 times). Then, he restored the neutral sitting posture, and at the end of the range of motion (ROM), he' tuck in" chin by pushing the chin with his fingers (10 to 15 times). Subsequently, the participant will be requested to return to the original position while the therapist one hand's forefinger placed alongside the participant's mandible (to stabilize the head at full retraction position), and the heel of the other hand placed on the first or second dorsal vertebra (to provide posterior-anterior force). The exercises then repeated five or six times in a Session. the session will be of 45 mins, 3 session per week.

Also known as: McKenzie protocol for neck pain
McKenzie protocol

In this group participants will receive Rhythmic stabilization, with Conventional physiotherapy treatment the flexion , extension exercises performed. During flexion pattern the experimenter stood at the right side of patient and used his tip of fingers at chin. The experimenter then put his left hand at anterior side of head to apply resistance. then extension pattern is resisted and asked patient to match my resistance. The experimenter provided resistance against right rotation and lateral flexion provided during the exercise in order to induce strong muscle contractions. 3 sessions of 45 minutes a week, over a period of 10 weeks.

Also known as: Rhythmic Stabilization technique in neck pain
Rhythmic stabilization technique

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 30-50
  • Localized chronic neck pain for more than 3 months.

You may not qualify if:

  • Participants suffering their neck pain was caused by any other complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghurki Trust Teaching Hospital

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammad Sanaullah, MS

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 18, 2023

First Posted

April 28, 2023

Study Start

February 1, 2023

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

September 25, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations