NCT05777434

Brief Summary

Neck pain is a common musculoskeletal disorder, involving discomfort and pain around the neck region, which results in limited neck function. Due to chronic neck pain, patient's neck function, cervical proprioception, ROM and cervical muscle strength is affected. Exercise is considered as one of the evidence-based modality to decrease pain, prevent further injury, increase muscle strength, endurance and flexibility, improve proprioception, and contribute and sustain normal life activities. In addition, recent studies suggest that exercises including not only neck but also scapulothoracic region might be more beneficial for the management of patients with chronic neck pain.Scapulothoracic stabilization exercises in addition to cervical stabilization exercises have the potential of improving this cervical sensorimotor control, however evidence is deficient Hence, this study was designed to evaluate the effectiveness of adding scapula-thoracic stabilization training to conventional physical therapy on pain and neck function in the patients with chronic neck pain.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

March 9, 2023

Last Update Submit

March 20, 2023

Conditions

Keywords

Chronic pain, proprioception, range of motion

Outcome Measures

Primary Outcomes (5)

  • Pain intensity

    Pain will be measured using the Visual Analog Scale (VAS)

    4 weeks

  • Neck Function

    Neck function of patients will be assessed using Neck Disability Index. A higher score indicates more disability

    4 Weeks

  • Cervical Proprioception

    : Cervical Proprioception of patients will be assessed using Cervical Joint Position Error Test. Reposition accuracy error will be determined in Lateral flexion and rotation (right \& left). A higher repositioning error indicates poor joint position sense or proprioception.

    4 Weeks

  • Cervical Range of Motion

    Cervical Proprioception of patients will be measured using inclinometer. Flexion, extension and lateral flexion will be measured.

    4 Weeks

  • Deep Cervical Flexor Strength

    Deep Cervical flexor strength of patients will be measured using CranioCervical Flexion Test in crook-lying position.

    4 Weeks

Study Arms (2)

Group A (Conventional Physical Therapy)

ACTIVE COMPARATOR

Patients in this group will recieve conventional physical therapy including hot pack and TENS for pain relief, axial elongtion exercises to correct posture, cervical isometrics and cervical stabilization exercises (cervical bracing with deep neck flexor activation followed by extremity ROM) along with general flexibility exercises. Each exercise would be performed with a hold time of 5-10 sec and 8-12 reps. A total of 12 sessions would be conducted over a period of 4 weeks.

Procedure: Conventional Physical Therapy for Chronic Neck Pain

Group B (Scapulothoracic Stabilization Exercises)

EXPERIMENTAL

Patients will recieve scapulothoracic stabilization exercises in addition to the convential physical therapy including hot pack, TENS, axial elongation, cervical isometrics and cervical stabilization exercises. SSE would include scapular adduction and shoulder external rotation, B/L shoulder extension with scapular retraction, Eccentric scapular retraction, Brügger exercise and Forward punch. Exercises would be given using latex Thera-Band, or acc. to patient strength for mild to moderate resistance. Each exercise would be performed with a hold time of 5-10 sec and 8-12 reps. A total of 12 sessions would be conducted over a period of 4 weeks.

Procedure: Conventional Physical Therapy for Chronic Neck PainProcedure: Scapulothoracic Stabilization Exercises

Interventions

Conventional physical therapy for Chronic Neck Pain will include hot pack and TENS for pain relief, axial elongtion exercises to correct posture, cervical isometrics and cervical stabilization exercises. After 2 weeks, functional training will be added. Sets and repetitions will be increased progressively.

Group A (Conventional Physical Therapy)Group B (Scapulothoracic Stabilization Exercises)

• Scapulothoracic stabilization exercises in addition to conventional physical therapy will include scapular adduction and shoulder external rotation, B/L shoulder extension with scapular retraction, Eccentric scapular retraction, Brügger exercise and Forward punch. Exercises would be given using latex Thera-Band, or acc. to patient strength for mild to moderate resistance. After 2 weeks, functional training will be added. Sets aand repetitions will be increased progressively.

Group B (Scapulothoracic Stabilization Exercises)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with Chronic neck pain greather than 3 months
  • Adults aged 18-45 years
  • Both Male and Female
  • Subjects with non-specific neck pain without specific identifiable etiology (infection, inflammatory disease etc)

You may not qualify if:

  • Patients with history of previous neck/ shoulder surgery
  • History of cervical spine injury or surgery
  • History of any psychological disorder.
  • Pregnant females.
  • Patient suffering from neck pain secondary to other conditions (neoplasm,neurological or vascular disease)
  • Patient experiencing neck pain due to other causes such as tumors, fractures, radiculopathy etc.
  • Patients who have received physiotherapy for neck pain from last 1 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Islamabad

Islamabad, Federal, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Neck PainChronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Manahil Shahid

    FUI

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manahil Shahid, MS-MSKPT*

CONTACT

Zara Khalid, PhD*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized controlled trial having two groups. One group will receive conventional physical therapy along with cervical stabilization exercises and the second will receive Scapulothoracic Stabilization Exercises in addition to Cervical Stabilization Exercises with conventional physical therapy. Both groups will be recruited concurrently.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2023

First Posted

March 21, 2023

Study Start

January 1, 2023

Primary Completion

June 15, 2023

Study Completion

July 1, 2023

Last Updated

March 21, 2023

Record last verified: 2023-03

Locations