NCT04674891

Brief Summary

This project was a Randomized control trial conducted to check the effects of Cervical Stabilization Exercises on Respiratory Strength in Chronic Neck Pain Patients with Forward Head Posture, duration of study was of 6 months, convenient sampling was done, subject following eligibility criteria from Jinnah Hospital Lahore, were randomly allocated in two groups via lottery method, baseline assessment was done, Group A participants were given baseline treatment protocol for 4 weeks which included 3 sessions per week. Heating Pad applied for 15 min and TENS (Transcutaneous Electric Nerve Stimulation) for 10 min. After that Cervical isometric exercises performed in sitting (10sec hold, 10 to 15 reps). Group B was experimental group and participants were given baseline treatment in addition to Cervical Stabilization exercises for 4 weeks which included 3 sessions per week. The baseline measurement was taken on day one for Numeric Pain Rating Scale (NRPS) and Neck Disability Index (NDI). Forward head posture assessed by measuring Cranio Vertebral Angle (CVA). Respiratory muscle strengths measured by Spirometer and SBC (single breath count). All the measurements repeated at the end of fourth week. Data was analyzed by using SPSS version 20.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

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

Study Start

First participant enrolled

March 30, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
Last Updated

March 8, 2021

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

December 16, 2020

Last Update Submit

March 4, 2021

Conditions

Keywords

NDI, NPRS, CVA, SBC

Outcome Measures

Primary Outcomes (1)

  • Numeric Pain rating scale

    The NPRS is the segmented numeric version of visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain. The common format is a horizontal bar or line. Similar to VAS, the NPRS is anchored by terms describing pain severity extremes.

    4th week

Secondary Outcomes (1)

  • Neck disability Index

    4th Week

Other Outcomes (2)

  • Spirometer

    4th Week

  • Single Breath Count( SBC)

    4th Week

Study Arms (2)

baseline physical therapy treatment

ACTIVE COMPARATOR

baseline physical therapy treatment ,Control group- Group A

Other: baseline physical therapy treatment

Cervical Stabilization exercises

EXPERIMENTAL

baseline physical therapy treatment along with Cervical Stabilization exercises- Experimental Group- Group B

Other: Cervical Stabilization exercises

Interventions

Group A was control group and the patients received Conventional treatment protocol for 4 weeks which included 3 sessions per week. Patients received hot pack for 15 min and TENS (Transcutaneous Electric Nerve Stimulation) for 10 min. After that Cervical isometric exercises will be performed in sitting (10sec hold,10 to 15 reps)

baseline physical therapy treatment

Group B was experimental group and received baseline physiotherapy treatment in addition to Cervical Stabilization exercises. Pillow was placed beneath cervical spine in supine position and guided patients to nod head as though they said 'yes' and asked them to hold for 10 seconds. 10 repetitions were done before progressing to the next target level. 4 weeks (3 sessions per week) * Hot pack: 10 min * TENS: 10 min * Cervical isometric exercises in sitting (10sec hold,10 to 15 reps) * Cervical Stabilization exercises (10 sec hold, 10 reps) On eligible participants baseline assessment was taken on day 1, post intervention assessment was taken at the end of 4th week.

Cervical Stabilization exercises

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic neck pain for more than 3 months.
  • Mild neck disability (NDI score 5-15)

You may not qualify if:

  • Neck pain secondary to trauma
  • Deformities of thoracic region or vertebral column
  • History of any thoracic or vertebral column surgery.
  • History of smoking
  • Patients with any other serious pathology/red flags

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital

Lahore, Punjab Province, Pakistan

Location

Related Publications (16)

  • Miranda IF, Wagner Neto ES, Dhein W, Brodt GA, Loss JF. Individuals With Chronic Neck Pain Have Lower Neck Strength Than Healthy Controls: A Systematic Review With Meta-Analysis. J Manipulative Physiol Ther. 2019 Oct;42(8):608-622. doi: 10.1016/j.jmpt.2018.12.008. Epub 2019 Nov 23.

    PMID: 31771837BACKGROUND
  • Migliarese S, White E. Review of Forward-Head Posture and Vestibular Deficits in Older Adults. Current Geriatrics Reports. 2019;8(3):194-201.

    BACKGROUND
  • Gurudut P, Welling A, Chodankar A. Effect of self-care exercises in forward head posture on craniovertebral angle and craniocervical flexion endurance: A pilot study. Indian Journal of Physical Therapy and Research. 2020;2(1):25.

    BACKGROUND
  • Son K-k, Cynn H-S, Lee J-H, Park D-H, Kim B-B. Effects of Deep Cervical Flexor Exercise with Visual Guide on Muscle Activity and Craniovertebral Angle in Subjects with Forward Head Posture. Korean Society of Physical Medicine. 2019;14(2):53-61.

    BACKGROUND
  • Koseki T, Kakizaki F, Hayashi S, Nishida N, Itoh M. Effect of forward head posture on thoracic shape and respiratory function. J Phys Ther Sci. 2019 Jan;31(1):63-68. doi: 10.1589/jpts.31.63. Epub 2019 Jan 10.

    PMID: 30774207BACKGROUND
  • Mathur H, Khan SA, Siddiqui ZA. Effect of forward head posture on swallowing: Review of Literature. 2019

    BACKGROUND
  • Herman PM, Vernon H, Hurwitz EL, Shekelle PG, Whitley MD, Coulter ID. Clinical Scenarios for Which Cervical Mobilization and Manipulation Are Considered by an Expert Panel to Be Appropriate (and Inappropriate) for Patients With Chronic Neck Pain. Clin J Pain. 2020 Apr;36(4):273-280. doi: 10.1097/AJP.0000000000000800.

    PMID: 31985500BACKGROUND
  • Alsultan F, De Nunzio AM, Rushton A, Heneghan NR, Falla D. Variability of neck and trunk movement during single- and dual-task gait in people with chronic neck pain. Clin Biomech (Bristol). 2020 Feb;72:31-36. doi: 10.1016/j.clinbiomech.2019.11.019. Epub 2019 Nov 28.

    PMID: 31809920BACKGROUND
  • Storto CJ, Garcez AS, Suzuki H, Cusmanich KG, Elkenawy I, Moon W, Suzuki SS. Assessment of respiratory muscle strength and airflow before and after microimplant-assisted rapid palatal expansion. Angle Orthod. 2019 Sep;89(5):713-720. doi: 10.2319/070518-504.1. Epub 2019 Mar 21.

    PMID: 30896250BACKGROUND
  • Kalita J, Kumar M, Misra UK. Serial single breath count is a reliable tool for monitoring respiratory functions in Guillain-Barre Syndrome. J Clin Neurosci. 2020 Feb;72:50-56. doi: 10.1016/j.jocn.2020.01.032. Epub 2020 Jan 22.

    PMID: 31982274BACKGROUND
  • Uysal SC, Tuzun EH, Eker L, Angin E. Effectiveness of the muscle energy technique on respiratory muscle strength and endurance in patients with fibromyalgia. J Back Musculoskelet Rehabil. 2019;32(3):411-419. doi: 10.3233/BMR-181287.

    PMID: 30475751BACKGROUND
  • Pawaria S, SuDhan DS, Kalra S. Effectiveness of Cervical Stabilisation Exercises on Respiratory Strength in Chronic Neck Pain Patients with Forward Head Posture-A Pilot Study. Journal of Clinical and Diagnostic Research. 2019;13(4).

    BACKGROUND
  • Lee H-j, Park H-s, Park J-m. The Effects of Cervical Stabilization Exercise on Neck Pain, Range of Motion, and Deep Cervical Muscle Strength in Patients With Chronic Neck Pain. The Journal of Korean Academy of Orthopedic Manual Physical Therapy. 2019;25(1):9-19

    BACKGROUND
  • Lee MH, Jang SH. The effects of the neck stabilization exercise on the muscle activity of trunk respiratory muscles and maximum voluntary ventilation of chronic stroke patients. J Back Musculoskelet Rehabil. 2019;32(6):863-868. doi: 10.3233/BMR-170839.

    PMID: 30958329BACKGROUND
  • Kim G-C, HwangBo P-N. Effects of cervical stabilization exercise using pressure biofeedback on neck pain, forward head posture and acoustic characteristics of chronic neck pain patients with forward head posture. Korean Society of Physical Medicine. 2019;14(1):121-9.

    BACKGROUND
  • Young IA PT, DSc, Dunning J PT, DPT, Butts R PT, PhD, Mourad F PT, DPT, Cleland JA PT, PhD. Reliability, construct validity, and responsiveness of the neck disability index and numeric pain rating scale in patients with mechanical neck pain without upper extremity symptoms. Physiother Theory Pract. 2019 Dec;35(12):1328-1335. doi: 10.1080/09593985.2018.1471763. Epub 2018 Jun 1.

    PMID: 29856244BACKGROUND

MeSH Terms

Conditions

Neck PainStroke

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Syed Shakil Ur Rehman

    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

December 16, 2020

First Posted

December 19, 2020

Study Start

March 30, 2020

Primary Completion

December 30, 2020

Study Completion

January 30, 2021

Last Updated

March 8, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations