Comparison Between Soft Tissue Mobilization and Strengthening Exercises in Management of Local Neck Syndrome

Sponsor

Health Education Research Foundation (HERF) (Other)

Overall Status

Completed

CT.gov ID

NCT05227963

Collaborator

(none)

Enrollment

Arms

64.5

Actual Duration (Months)

Study Details

Study Description

Brief Summary

A single-blinded, parallel-group randomized controlled trial was conducted at the national institute of rehabilitation medicine, Pakistan, from April to July 2016, on 30 females who were recruited through non-probability convenient sampling technique and randomly allocated to the experimental and control group.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain Neck Pain	Other: soft tissue mobilization Other: neck isometric strengthening exercises	N/A

Detailed Description

The experimental group received STM and neck isometric strengthening exercises, whereas the control group received neck isometrics strengthening exercises only. Numeric Pain Rating Scale (NPRS) was used to assess the pain intensity, while Neck Disability Index (NDI) was used to assess the neck-related disability. The data was collected pre-, during, and post-intervention. Repeated measure analysis of variance (RM ANOVA) was used to analyze within the group changes, while independent t-test was used to analyze the differences between the groups. Data were analyzed by using SPSS version 21.

This study describes the comparative effectiveness of STM when used as adjunct to strengthening exercises and when strengthening exercises are used alone for the management of TNS. According to the results of this study, STM in combination with neck isometric strengthening exercises as well as exercises alone were effective for managing neck pain and functional disability when a comparison was made within the groups.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

The randomized control study was conducted in two groups,one was experimental group received soft tissue mobilization and other was control group received strengthening exercises with supportive treatment for both groups.The randomized control study was conducted in two groups,one was experimental group received soft tissue mobilization and other was control group received strengthening exercises with supportive treatment for both groups.

Masking:

Single (Investigator)

Masking Description:

Non-probability convenient sampling technique was used to recruit the sample through lottery method into two groups.

Primary Purpose:

Supportive Care

Official Title:

Comparison Between Soft Tissue Mobilization and Strengthening Exercises in Management of Local Neck Syndrome

Actual Study Start Date :

Apr 4, 2016

Actual Primary Completion Date :

May 10, 2016

Actual Study Completion Date :

Aug 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group(Group A) Experimental Group received soft tissue mobilization with neck isometric strengthening exercises.	Other: soft tissue mobilization In this group, each participants received 45-minutes long session that includes 25-minutes of soft tissue mobilization and 20-minutes of neck isometric strengthening exercises. In each session, patient was seated on chair and sustained pressure, direct oscillation, perpendicular mobilization, parallel mobilization, and friction massage was applied on the neck musculature for a minute followed by a release for 30 seconds. This protocol was repeated three times in each session. Each session was repeated four-times a week for two-weeks (a total eight sessions). Other: neck isometric strengthening exercises In this group, each participant received 20-minutes long session. Each session started in seated position and participants were asked to perform flexion, extension, side bending and rotation against resistance. During flexion movement, therapist placed hand on forehead and asked patient to move the neck forward, while in extension, therapist hand was placed at back of the head and patient had to move neck in backward direction. However, in side bending and rotation- therapist hand was placed at lateral side of the head and asked patient to side bend the neck and look at shoulder in the same direction respectively. Each session was repeated four-times a week for two-weeks (a total eight sessions).
Other: Control group (Group B) Control group received neck isometric strengthening exercises alone.	Other: neck isometric strengthening exercises In this group, each participant received 20-minutes long session. Each session started in seated position and participants were asked to perform flexion, extension, side bending and rotation against resistance. During flexion movement, therapist placed hand on forehead and asked patient to move the neck forward, while in extension, therapist hand was placed at back of the head and patient had to move neck in backward direction. However, in side bending and rotation- therapist hand was placed at lateral side of the head and asked patient to side bend the neck and look at shoulder in the same direction respectively. Each session was repeated four-times a week for two-weeks (a total eight sessions).

Arm

Intervention/Treatment

Experimental: Experimental Group(Group A)

Experimental Group received soft tissue mobilization with neck isometric strengthening exercises.

Other: soft tissue mobilization

In this group, each participants received 45-minutes long session that includes 25-minutes of soft tissue mobilization and 20-minutes of neck isometric strengthening exercises. In each session, patient was seated on chair and sustained pressure, direct oscillation, perpendicular mobilization, parallel mobilization, and friction massage was applied on the neck musculature for a minute followed by a release for 30 seconds. This protocol was repeated three times in each session. Each session was repeated four-times a week for two-weeks (a total eight sessions).

Other: neck isometric strengthening exercises

In this group, each participant received 20-minutes long session. Each session started in seated position and participants were asked to perform flexion, extension, side bending and rotation against resistance. During flexion movement, therapist placed hand on forehead and asked patient to move the neck forward, while in extension, therapist hand was placed at back of the head and patient had to move neck in backward direction. However, in side bending and rotation- therapist hand was placed at lateral side of the head and asked patient to side bend the neck and look at shoulder in the same direction respectively. Each session was repeated four-times a week for two-weeks (a total eight sessions).

Other: Control group (Group B)

Control group received neck isometric strengthening exercises alone.

Other: neck isometric strengthening exercises

Outcome Measures

Primary Outcome Measures

Numerical pain rating scale (NPRS) [upto 2 weeks]
NPRS was used to assess the pain intensity. The 11-point numeric scale ranging from 0-10; 0 means no pain while 10 means worst possible pain.
Neck disability index (NDI) [upto 2 weeks.]
NDI was used to assess the neck-related disability. Of the 50 score, 0-4 means no disability while 35-50 means severe disability.
Neck range of motion [upto 2 weeks .]
Goniometer was used to measure the range of motion of neck.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria

:• Age above 30 and below 75 years

Patients having local neck pain included
Female included
With chronic neck syndrome (> month)

Exclusion Criteria:

Age below 30 and more than 75 years
Patients having radiating pain excluded
Male excluded.
With acute neck syndrome (< 3 month)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Health Education Research Foundation (HERF)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Javairia Javaid, Senior Physiotherapist, Health Education Research Foundation (HERF)

ClinicalTrials.gov Identifier:

NCT05227963

Other Study ID Numbers:

Ref.No.Research/21

First Posted:

Feb 8, 2022

Last Update Posted:

Feb 8, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Javairia Javaid, Senior Physiotherapist, Health Education Research Foundation (HERF)

Assessment

Neck pain

Pain measurements

Patient outcome assessment

Treatment outcome

Additional relevant MeSH terms:

Chronic Pain

Neck Pain

Study Results

No Results Posted as of Feb 8, 2022