NCT05393973

Brief Summary

The study will be a randomized clinical trial to determine the effects of core stability versus swiss ball exercises on pain, range of motion and function in patients with chronic neck pain. A sample of 42 patients having neck pain since last 3 months will be taken from physical therapy department of "Bahawalpur medical \& dental hospital" and will be divided into two groups each with 21 patients. Patient of any gender(male or female) with no history of neck surgery or any systemic disease will be considered. Group A will receive core stability exercises along with conventional physical therapy while group B will receive swiss ball exercises along with the conventional physical therapy protocol. The conventional physical therapy protocol will include a hot pack, and cervical stretches. The session will be around 30-45 minutes for each patient with three sessions per week on alternate days. A total of four-week treatment regime will be given to the patients and an assessment of patient's pain, range of motion, and function with NPRS (numeric pain rating scale), goniometry, and NDI (neck disability index) will be done at the baseline and after 4 weeks of treatment, data will be analyzed by using SPSS version 21, after the completion of treatment at four weeks.

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 May 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

May 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

May 23, 2022

Last Update Submit

April 18, 2023

Conditions

Keywords

Neck painPostureRange of motionCore Stability

Outcome Measures

Primary Outcomes (3)

  • NPRS

    Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.

    4th week

  • NDI

    The NDI has become a standard instrument for measuring self-rated disability due to neck pain. Each of the 10 items scores from 0 to 5. The maximum score is 50

    4th week

  • Goniometric measurement of neck ROM

    A goniometer is an instrument which measures the available range of motion at a joint.

    4th Week

Study Arms (2)

Core stability exercises along with conventional physical therapy

EXPERIMENTAL

Core stability exercises

Other: Core stability exercises along with conventional physical therapy

Swiss ball exercises along with the conventional physical therapy protocol

EXPERIMENTAL

Swiss ball exercises

Other: Swiss ball exercises along with the conventional physical therapy protocol

Interventions

Core stability exercises included neck isometric exercises(flexion, extension, lateral flexion, rotation), chin tuck, chin tuck into towel, cervical extension + 10 minutes hot pack+ 10 minutes stretching (cervical flexors, extensors, rotators), session will be of 30-40 minutes, three times a week, for 4 weeks duration. Chin Tuck: In standing subject pulls back the chin( as if trying to make a double chin) while keeping the eyes level. This will be done for 15 repetitions. Cervical extension: In a standing position, the subject grasps the base of the neck, with both hands while extending the neck as far as possible. This will be done for 15 repetitions

Core stability exercises along with conventional physical therapy

Swiss ball exercise will be executed in the following order, assume supine posture on the treatment bed by fully extending their legs and putting them back on the bed in the most comfortable posture with hands on the abdomen. Second, while in the supine posture, support the head with one hand and insert a small Swiss ball near the back of the head with the other hand. Third, after having contacted the ball to the area below the back of the head, slowly turn the head and neck in the shape of the number '8'. Fourth, after having set 3 repetitions of rotating the head and neck for 10 seconds and then taking 10 seconds of general resting as 1 set of exercise, a total of 3 sets of exercise were executed with 1 minute of general resting taken between each set of exercise. Then perform neck flexion, extension, side bending, and rotation, hold each movement for 10 seconds + Hot pack (10 minutes) + 10 minutes of cervical stretching. Perform the exercise three times a week for 4 weeks duration.

Swiss ball exercises along with the conventional physical therapy protocol

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both genders (male \& female)
  • Age group 20-40 years
  • History of neck pain for more than 3 months

You may not qualify if:

  • History of any neck surgery
  • Neoplasms
  • Any systemic disease
  • Bony disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bhawalpur Medical & Dental College, Bhawalpur

Chak Four Hundred Fifty-four, Punjab Province, 54000, Pakistan

Location

Related Publications (9)

  • Gupta BD, Aggarwal S, Gupta B, Gupta M, Gupta N. Effect of Deep Cervical Flexor Training vs. Conventional Isometric Training on Forward Head Posture, Pain, Neck Disability Index In Dentists Suffering from Chronic Neck Pain. J Clin Diagn Res. 2013 Oct;7(10):2261-4. doi: 10.7860/JCDR/2013/6072.3487. Epub 2013 Oct 5.

    PMID: 24298492BACKGROUND
  • Hoy DG, Protani M, De R, Buchbinder R. The epidemiology of neck pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):783-92. doi: 10.1016/j.berh.2011.01.019.

    PMID: 21665126BACKGROUND
  • Kim BJ. Effects of Neck Stabilization and Swiss Ball Exercises on the Recovery from Fatigue of Neck Muscles in Turtle Neck Posture: Preliminary Experimental Study. Journal of International Academy of Physical Therapy Research. 2018;9(2):1498-507.

    BACKGROUND
  • Noormohammadpour P, Kordi M, Mansournia MA, Akbari-Fakhrabadi M, Kordi R. The Role of a Multi-Step Core Stability Exercise Program in the Treatment of Nurses with Chronic Low Back Pain: A Single-Blinded Randomized Controlled Trial. Asian Spine J. 2018 Jun;12(3):490-502. doi: 10.4184/asj.2018.12.3.490. Epub 2018 Jun 4.

    PMID: 29879777BACKGROUND
  • Rajalaxmi V, Manickam M, Srilakshmi M, Arunselvi J, Jayabarathi R, Anupreethi P, et al. The role of multistep core stability exercise with and without conventional neck exercises in the treatment of chronic non-specific neck pain a randomized controlled trial. Biomedicine. 2020;40(2):232-5.

    BACKGROUND
  • He Y, Sun W, Zhao X, Ma M, Zheng Z, Xu L. Effects of core stability exercise for patients with neck pain: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2019 Nov;98(46):e17240. doi: 10.1097/MD.0000000000017240.

    PMID: 31725601BACKGROUND
  • Ahn JA, Kim JH, Bendik AL, Shin JY. Effects of stabilization exercises with a Swiss ball on neck-shoulder pain and mobility of adults with prolonged exposure to VDTs. J Phys Ther Sci. 2015 Apr;27(4):981-4. doi: 10.1589/jpts.27.981. Epub 2015 Apr 30.

    PMID: 25995537BACKGROUND
  • Cho H-Y, Park Y-J, Moon H-H, Park S-S, Kang G-M, Yoon W-Y, et al. The effect of swiss ball stabilisation exercise on deep and superficial cervical muscle and pain in patients with chronic neck pain. Indian Journal of Science and Technology. 2015;8:14.

    BACKGROUND
  • Correa EC, Berzin F. Mouth Breathing Syndrome: cervical muscles recruitment during nasal inspiration before and after respiratory and postural exercises on Swiss Ball. Int J Pediatr Otorhinolaryngol. 2008 Sep;72(9):1335-43. doi: 10.1016/j.ijporl.2008.05.012. Epub 2008 Jul 7.

    PMID: 18603307BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Syed Shakil-ur Rehman

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

May 26, 2022

Study Start

May 30, 2022

Primary Completion

December 30, 2022

Study Completion

January 30, 2023

Last Updated

April 19, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations