NCT05021497

Brief Summary

Pain is an "unpleasant sensory and emotional experience (associated with actual or potential tissue damage". Chronic pain is a sensation of hyperalgia to muscles, ligaments and skin on both active and passive movements. Chronic pain has a tendency to prevent people from working and exercising

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration 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

Study Start

First participant enrolled

February 15, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2023

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

2.4 years

First QC Date

August 23, 2021

Last Update Submit

December 12, 2024

Conditions

Neck Pain

Keywords

PainRange of motionKinesiophobiaForward head posture

Outcome Measures

Primary Outcomes (4)

  • Numeric pain rating scale

    The NPRS is an 11-point numeric scale, it is the segmented numeric version of the visual analog scale. Subjects will be asked to mark/select a whole number for 0-10 that best describes their perceived pain intensity of the last 24 hours. Assessment to be done at baseline, after 1st session, at 3rd week and at 6th week

    six weeks

  • Neck Disability Index

    it is a 10-item self-report questionnaire that measures the patient's disability related to his/her neck pain. It is the most commonly used questionnaire for neck disability; its reliability and validity has been demonstrated in many literatures and languages. Assessment to be done at baseline, after 1st session, at 3rd week and at 6th week

    six weeks

  • Goniometer for Cervical Range of Motion

    The active cervical range of motion (CROM) will be measured in sitting posture by using a universal goniometer, which consists of two arms; one that is stationary and one that is moveable. Assessment to be done at baseline, after 1st session, at 3rd week and at 6th week

    six weeks

  • Tampa Scale of Kinesiophobia

    Tampa Scale of Kinesiophobia (TSK). TSK is a 17-items questionnaire based on the evaluation of fear of movement, fear of physical activity and fear of re-injury in patients suffering from chronic musculoskeletal pain. It is the most widely used fear avoidance behavior questionnaire with good level of reliability and validity as documented in different literatures. TSK is composed of 17 items with score ranging from 1to 4 for each item, ultimately having a total score ranging from 17-68.Assessment to be done at baseline, after 1st session, at 3rd week and at 6th week

    six weeks

Secondary Outcomes (2)

  • Forward Head Posture:

    six weeks

  • Global Perceived Effect Questionnaire:

    six week

Study Arms (2)

Global Positional Re-education

EXPERIMENTAL

Global Positional Re-education

Other: Global Positional Re-education

Conventional Physical Therapy Program

ACTIVE COMPARATOR

Conventional therapy will consist of a combination of manual techniques

Other: Conventional Physical Therapy Program

Interventions

Global Positional Re-educationOTHER

A series of gentle active movements and postures aimed at realigning joints and stretching shortened muscles. GPR includes 8 therapeutic postures in lying, sitting and standing.

Global Positional Re-education
Conventional Physical Therapy ProgramOTHER

Axial traction will be given for 5 minutes, followed by mobilization of the muscle fascia along with static stretching of the scalene, levator scapulae, upper trapezius, sternocleidomastoid and pectoralis minor muscles.

Conventional Physical Therapy Program

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chronic non-specific neck pain ≥ 3 months.
  • No prior medication and Physical Therapy interventions from last 3 months.
  • Pain: moderate level (6 on NPRS).

You may not qualify if:

  • History of any trauma .
  • History of any psychological condition.
  • Specific causes of Neck Pain (e.g., systemic, rheumatic, neuromuscular diseases).
  • Presence of central and peripheral neurological sign.
  • Spinal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Islamabad Physiotherapy and Rehabilitation Centre (IPRC)

Islamabad, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Neck PainPainKinesiophobia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Maria Khalid, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2021

First Posted

August 25, 2021

Study Start

February 15, 2021

Primary Completion

July 10, 2023

Study Completion

July 10, 2023

Last Updated

December 17, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)