NCT05298631

Brief Summary

the objective of this randomized clinical trial is to compare the effectiveness of neck stabilization exercises versus neck dynamic exercises in patients having non specific neck pain with forward head posture for pain intensity, correction of forward head posture, increasing Range of movement and decrease functional disability. the study is being conducted at physiotherapy department of institute of physical medicine and rehabilitation (Dow university of health sciences) total 60 patients with non specific neck pain with forward head posture recruited by non-probability sampling technique initially screening done by consultant physicians who is blinded to the treatment given to patients. patient are included in study who fulfill inclusion criteria and sign the consent form. patients then randomly allocated to both treatment groups using computer generated randomization sheet. baseline assessment is taken at first session after providing 9 treatment of stabilizing exercises to group1 and dynamic exercises to group 2 session post assessment will be done on goniometry, NDI, VAS and plumb line at last session at third week.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

April 6, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2023

Completed
Last Updated

May 8, 2023

Status Verified

May 1, 2023

Enrollment Period

10 months

First QC Date

March 17, 2022

Last Update Submit

May 5, 2023

Conditions

Keywords

Neck AchesIsotonic ContractionsMuscle StrengthRehabilitation ExercisesTreatment

Outcome Measures

Primary Outcomes (4)

  • Change in pain intensity with Visual analog scale (VAS) in cm

    VAS will be used for assessment of pain intensity on 10 cm straight line with marking from 0 to 10 (0 means no pain and 10 means worst pain possible) patients pain is recorded at baseline at the start of 1st session than change in pain intensity (decrease) will be assessed at the end of 9th session at week 3.

    Baseline and 3 weeks

  • Change in disability with Neck disability index questionnaire (NDI) scores

    NDI will be used for the assessment of disability due to neck pain. NDI is a ten item questionnaire each question has 6 responses from 0 no disability to 5 complete disability (score of less than 4 indicates no disability, 5-14 mild disability, 15-24 moderate disability, 25-34 severe disability, and scores greater than 35 complete disability) used to assess disability associated with neck pain and whiplash injury. patients disability is recorded at baseline at the start of 1st session than change in disability (decrease) will be assessed at the end of 9th session at week 3.

    Baseline and 3 weeks

  • Change in neck range of motions with goniometer in degrees

    Goniometry will be used for the assessment of change in available range of motion of around neck joint in degrees. the therapist assess the range of motion using goniometer in flexion, extension, lateral flexion(right), lateral flexion(left), rotation(right), rotation(left). patients ROM is recorded at baseline at the start of 1st session than change in ROM (increase) will be assessed at the end of 9th session at week 3.

    Baseline and 3 weeks

  • Change in ear position with reference to shoulder Plumb line measurement in inches

    Plumb line measurement will be used for the assessment of forward head posture using body landmarks such as ear lobe or mastoid process and shoulder alignment in inches. patients forward head is recorded at baseline at the start of 1st session than change in forward head (postural correction) will be assessed at the end of 9th session at week 3.

    Baseline and 3 weeks

Study Arms (2)

Treatment group 1: stabilization exercises

EXPERIMENTAL

stabilization exercises 1. Chin tuck 2. Cervical extension 3. Shoulder shrugs 4. Shoulder rolls 5. Scapular retraction (15 repetitions 1 set) with TENS(10 mins before each session for 10 min at the back of the neck), stretching of trapezius, Pectorals minor, sternocleidomastoid, levator scapulae (5 rep 10 sec hold 1 set in both sides ) and cold pack (10 min at the back of neck at the end of each session)

Other: Stabilization exercises

Treatment group 2: dynamic exercises

ACTIVE COMPARATOR

dynamic exercises 1. Cervical extension-dynamic isometric. 2. Cervical Flexion-Dynamic isometric. 3. Chest flies exercises (15 repetitions 1 set) with TENS(10 mins before each session for 10 min at the back of the neck), stretching of trapezius, Pectorals minor, sternocleidomastoid, levator scapulae (5 rep 10 sec hold 1 set in both sides ) and cold pack (10 min at the back of neck at the end of each session)

Other: Dynamic exercises

Interventions

The activation of deep cervical muscle to reduce the activity of surface muscles is known as stabilization exercises

Treatment group 1: stabilization exercises

The exercises in which muscle tension remains constant but muscle length changes is known as dynamic exercises

Treatment group 2: dynamic exercises

Eligibility Criteria

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

You may qualify if:

  • Patients with nonspecific neck pain more than 3 weeks less than 6 months.
  • Patients with forward head posture on plumb line assessment.
  • Pain on VAS moderate 4-7
  • NDI score with moderate; 50-64%.
  • Age ranges from 18-40.

You may not qualify if:

  • Previous history of any accident (whiplash), fracture, tumor etc.
  • Patients not willing to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sindh Institute of Physical Medicine and Rehabilitation

Karachi, Sindh, 75600, Pakistan

Location

Related Publications (1)

  • Batool A, Soomro RR, Baig AAM. Comparing the effects of neck stabilization exercises versus dynamic exercises among patients having nonspecific neck pain with forward head posture: a randomized clinical trial. BMC Musculoskelet Disord. 2024 Sep 4;25(1):707. doi: 10.1186/s12891-024-07749-8.

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aftab Ahmed Mirza Baig, MSAPT

    Sindh Institute of Physical Medicine and Rehabo

    STUDY DIRECTOR
  • Rabail Rani Soomro, MSPT

    Sindh Institute of Physical Medicine and Rehabilitation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
outcome assessor will be blinded to the treatment provided to both treatment groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: it is a randomized clinical trial. total 60 patients will be recruited 30 in each group. both groups are treatment group. treatment of group 1 is stabilization exercises and group 2 is dynamic exercises. patients are allocated randomly randomization is done by computer generated software sheet
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 17, 2022

First Posted

March 28, 2022

Study Start

April 6, 2022

Primary Completion

January 17, 2023

Study Completion

January 21, 2023

Last Updated

May 8, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations