NCT04556955

Brief Summary

The aim of this research is to compare the effects of post isometric relaxation and graston technique in mechanical neck pain. Post isometric relaxation and graston effects on pain , cervical range of motion and function. A randomized controlled trial was done at Max health hospital G-8 markaz Islamabad . The sample size was 20. The Participants were divided into two groups,10 participants in group A (post iso metric relaxation) and 10 in group B (Graston technique ) . The study duration was 6 months. Sampling technique applied was purposive sampling technique Randomized through sealed enveloped method . Only 18 to 50 years participants with mechanical neck pain were included in the study . Outcome measure Tools used in this study were Numerical pain rating scale (NPRS) ,inclinometer for cervical ROM, Algometer for pain pressure threshold and Neck disability index for assessing functional disability . Data analyzed through SPSS version 20.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 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

April 4, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

7 months

First QC Date

September 16, 2020

Last Update Submit

November 10, 2020

Conditions

Keywords

Post isometric relaxationGraston techniqueMechanical neck pain

Outcome Measures

Primary Outcomes (2)

  • Numeric Pain Rating Scale (NPRS) for pain.

    Numeric Pain Rating Scale (NPRS) for pain : is a unidimensional measure of pain intensity .The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") 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.

    12th day.

  • Cervical range of motion by using Inclinometer

    Measuring Cervical flexion, extension , Right side bending , left side bending , right rotation and Left rotation

    12th day

Secondary Outcomes (2)

  • Neck disability index for assessing functional status

    12th day

  • Algometry for assessing pressure pain threshold for trigger points.

    12th day

Study Arms (2)

post isometric relaxation and exercises

PLACEBO COMPARATOR

Group A included Post Isometric Relaxation, 5 rep , 20% isometric contraction 10 sec , 20 sec of stretch hold beyond resistance barrier and conventional exercise program ; this program included Hot pack placed over the painful area in cervical region before the treatment ( 20 minutes).Strengthening exercises for deep neck flexors, rhomboids, lower trapezius and serratus anterior due to weak muscles (2 sets of 10 repetitions once a day) Stretching exercises for pectoralis muscles (20-second hold, 5 repetitions).This exercise protocol was for 4 weeks and 3 sessions per week. Measurements taken at baseline level and at the End of treatment, i.e. ROM, pain intensity by NPRS and PPT , functional disability.

Other: post isometric relaxation

Graston technique and exercises

EXPERIMENTAL

Group B included Graston Technique to Upper Trapezius and Levator Scapulae.This instrumented-assisted soft tissue massage applied with deeper pressure to the area of concern.The protocol consist of Longitudinal stroking parallel to muscle fiber for 1min , spin over trigger points for 1 min using knob of instrument and fanning for 2 min Hot pack placed over the painful area in cervical region before the treatment ( 20 minutes).Strengthening exercises for deep neck flexors, rhomboids, lower trapezius and serratus anterior due to weak muscles (2 sets of 10 repetitions once a day) Stretching exercises for pectoralis muscles (20-second hold, 5 repetitions). This exercise protocol was for 4 weeks and 3 sessions per week. Measurements taken at baseline level and at the END of treatment , i.e. ROM, pain intensity by NPRS and PPT , functional disability.

Device: Graston technique

Interventions

Experimental group included Graston technique :The protocol consist of Longitudinal stroking parallel to muscle fiber for 1min , spin over trigger points for 1 min using knob of instrument and fanning for 2 min.

Graston technique and exercises

Post Isometric Relaxation, 5 rep , 20% isometric contraction 10 sec , 20 sec of stretch hold beyond resistance barrier

post isometric relaxation and exercises

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Symptoms of Mechanical neck pain 4-12 weeks.
  • Neck pain rating on NPRS (4-8 )
  • Palpable pain on Active or latent trigger points

You may not qualify if:

  • signs of serious pathology (e.g., malignancy, inflammatory disorder, infection)
  • history of cervical spine surgery in previous 12 months
  • history of trauma or fractures in cervical spine
  • signs of cervical radiculopathy
  • Vascular syndromes such as basilar insufficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Railway General Hospital.

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (23)

  • Binder AI. Cervical spondylosis and neck pain. BMJ. 2007 Mar 10;334(7592):527-31. doi: 10.1136/bmj.39127.608299.80. No abstract available.

    PMID: 17347239BACKGROUND
  • Fejer R, Kyvik KO, Hartvigsen J. The prevalence of neck pain in the world population: a systematic critical review of the literature. Eur Spine J. 2006 Jun;15(6):834-48. doi: 10.1007/s00586-004-0864-4. Epub 2005 Jul 6.

    PMID: 15999284BACKGROUND
  • Osama M, Shakil Ur Rehman S. Effects of static stretching as compared to autogenic inhibition and reciprocal inhibition muscle energy techniques in the management of mechanical neck pain: a randomized controlled trial. J Pak Med Assoc. 2020 May;70(5):786-790. doi: 10.5455/JPMA.9596.

    PMID: 32400728BACKGROUND
  • Childs JD, Cleland JA, Elliott JM, Teyhen DS, Wainner RS, Whitman JM, Sopky BJ, Godges JJ, Flynn TW; American Physical Therapy Association. Neck pain: Clinical practice guidelines linked to the International Classification of Functioning, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association. J Orthop Sports Phys Ther. 2008 Sep;38(9):A1-A34. doi: 10.2519/jospt.2008.0303. Epub 2008 Sep 1.

    PMID: 18758050BACKGROUND
  • 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
  • Misailidou V, Malliou P, Beneka A, Karagiannidis A, Godolias G. Assessment of patients with neck pain: a review of definitions, selection criteria, and measurement tools. J Chiropr Med. 2010 Jun;9(2):49-59. doi: 10.1016/j.jcm.2010.03.002.

    PMID: 21629550BACKGROUND
  • Cote P, Cassidy DJ, Carroll LJ, Kristman V. The annual incidence and course of neck pain in the general population: a population-based cohort study. Pain. 2004 Dec;112(3):267-273. doi: 10.1016/j.pain.2004.09.004.

    PMID: 15561381BACKGROUND
  • Stephenson JL, Christou EA, Maluf KS. Discharge rate modulation of trapezius motor units differs for voluntary contractions and instructed muscle rest. Exp Brain Res. 2011 Jan;208(2):203-15. doi: 10.1007/s00221-010-2471-4. Epub 2010 Nov 10.

    PMID: 21063691BACKGROUND
  • Lundberg U, Kadefors R, Melin B, Palmerud G, Hassmen P, Engstrom M, Dohns IE. Psychophysiological stress and EMG activity of the trapezius muscle. Int J Behav Med. 1994;1(4):354-70. doi: 10.1207/s15327558ijbm0104_5.

    PMID: 16250795BACKGROUND
  • Bruflat AK, Balter JE, McGuire D, Fethke NB, Maluf KS. Stress management as an adjunct to physical therapy for chronic neck pain. Phys Ther. 2012 Oct;92(10):1348-59. doi: 10.2522/ptj.20110489. Epub 2012 Jun 14.

    PMID: 22700538BACKGROUND
  • Munoz-Munoz S, Munoz-Garcia MT, Alburquerque-Sendin F, Arroyo-Morales M, Fernandez-de-las-Penas C. Myofascial trigger points, pain, disability, and sleep quality in individuals with mechanical neck pain. J Manipulative Physiol Ther. 2012 Oct;35(8):608-13. doi: 10.1016/j.jmpt.2012.09.003.

    PMID: 23158466BACKGROUND
  • Mejuto-Vazquez MJ, Salom-Moreno J, Ortega-Santiago R, Truyols-Dominguez S, Fernandez-de-Las-Penas C. Short-term changes in neck pain, widespread pressure pain sensitivity, and cervical range of motion after the application of trigger point dry needling in patients with acute mechanical neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Apr;44(4):252-60. doi: 10.2519/jospt.2014.5108. Epub 2014 Feb 25.

    PMID: 24568260BACKGROUND
  • Fernandez-de-las-Penas C, Alonso-Blanco C, Miangolarra JC. Myofascial trigger points in subjects presenting with mechanical neck pain: a blinded, controlled study. Man Ther. 2007 Feb;12(1):29-33. doi: 10.1016/j.math.2006.02.002.

    PMID: 21882489BACKGROUND
  • Fredin K, Loras H. Manual therapy, exercise therapy or combined treatment in the management of adult neck pain - A systematic review and meta-analysis. Musculoskelet Sci Pract. 2017 Oct;31:62-71. doi: 10.1016/j.msksp.2017.07.005. Epub 2017 Jul 21.

    PMID: 28750310BACKGROUND
  • Thornton, C., The effects of thoracic manipulation in the treatment of mechanical neck pain: a meta-analysis. 2018.

    BACKGROUND
  • Coulter ID, Crawford C, Vernon H, Hurwitz EL, Khorsan R, Booth MS, Herman PM. Manipulation and Mobilization for Treating Chronic Nonspecific Neck Pain: A Systematic Review and Meta-Analysis for an Appropriateness Panel. Pain Physician. 2019 Mar;22(2):E55-E70.

    PMID: 30921975BACKGROUND
  • • El Laithy, M.H. and K.Z. Fouda, Effect of post isometric relaxation technique in the treatment of mechanical neck pain. 2018

    BACKGROUND
  • Phadke A, Bedekar N, Shyam A, Sancheti P. Effect of muscle energy technique and static stretching on pain and functional disability in patients with mechanical neck pain: A randomized controlled trial. Hong Kong Physiother J. 2016 Apr 14;35:5-11. doi: 10.1016/j.hkpj.2015.12.002. eCollection 2016 Dec.

    PMID: 30931028BACKGROUND
  • Mahajan, R., C. Kataria, and K. Bansal, Comparative effectiveness of muscle energy technique and static stretching for treatment of subacute mechanical neck pain. Int J Health Rehabil Sci, 2012. 1(1): p. 16-21

    BACKGROUND
  • Crothers AL, French SD, Hebert JJ, Walker BF. Spinal manipulative therapy, Graston technique(R) and placebo for non-specific thoracic spine pain: a randomised controlled trial. Chiropr Man Therap. 2016 May 16;24:16. doi: 10.1186/s12998-016-0096-9. eCollection 2016.

    PMID: 27186365BACKGROUND
  • • Gupta, S., P. Jaiswal, and D. Chhabra, A comparative study between postisometric relaxation and isometric exercises in non-specific neck pain. Journal of exercise science and physiotherapy, 2008. 4(2): p. 88

    BACKGROUND
  • Joshi R, Rathi M. Effect of Muscle Energy Technique versus Positional Release Technique on Pain and Functions in Patients with Trapezitis-A Comparative Study. Internafional Journal of Science and Research. 2017;6:2113-5.

    BACKGROUND
  • • Kumari C, Sarkar B, Banerjee D, Alam S, Sharma R, Biswas A. Efficacy of muscle energy technique as compared to proprioceptive neuromuscular facilitation technique in chronic mechanical neck pain: A randomized controlled trial. Int J Health Sci Res. 2016; 6:152-61.

    BACKGROUND

Study Officials

  • Lal Gul Khan

    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

September 16, 2020

First Posted

September 21, 2020

Study Start

April 4, 2020

Primary Completion

November 9, 2020

Study Completion

November 9, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations