NCT04993118

Brief Summary

The purpose of the study is to find the effects of integrated neuromuscular inhibition technique on upper trapezius trigger points in patients with non specific neck pain. A randomized control trial was conducted at Iqbal hospital. The sample size was 24calculated through open-epitool.But 30 patients were added in the study to increase the statistical power of analysis.The participants were divided into two interventional groups each having 15 participants. The study duration was six months. Sampling technique applied was Purposive sampling for recruitment and group randomization using sealed envelope method. Only 25 to 45 years participants (both male and female) with upper trapezius trigger points and non specific neck pain of less than 3 months were included in the study. Tools that were used in this study are NDI questionnaire, NPRS and inclinometer. Data was collected at baseline , 2nd and 4th of treatment. Data was analyzed through SPSS version 20.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 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

May 14, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

April 10, 2021

Last Update Submit

August 5, 2021

Conditions

Keywords

Neck painTrapezius trigger pointsINIT

Outcome Measures

Primary Outcomes (2)

  • Neck Disability Index

    Neck Disability Index (NDI) questionnaire ( for measuring neck disability). Total score 50,minimum score is 0 and maximu,m score is 50 parameter minimum and max

    6 months

  • Numeric Pain Rating Scale

    NPRS, for measuring pain intensity.minimum score is o and maximum is 10

    6 months

Secondary Outcomes (4)

  • range of motion (Cervical flexion)

    6 months

  • range of motion (Cervical extention)

    6 months

  • range of motion (Cervical side bending,right left )

    6 months

  • range of motion (Cervical rotation right left,)

    6 months

Study Arms (2)

Integrated Neuromuscular inhibition technique

EXPERIMENTAL

Experimental group received Integrated neuromuscular inhibition technique. At first ischemic compression was given using a pincer grip over the active trigger point till the tissue barrier was felt .The process was repeated till the tension reduced for 90 seconds.Ischemic compression was followed by the application of strain counterstrain. M If pain was reproduced the pressure was maintained over the active trigger point as the position of ease was identified. Once the position of ease was identified, it was held for 90 seconds and repeated for three to five repetitions. Muscle energy technique was applied as last part of iINIT.Each isometric contraction was held for 7-10 seconds and was followed by further contralateral side bending, flexion, and ipsilateral rotation to maintain the soft tissue stretch. Each stretch was held for 30 seconds and was repeated three to five times per treatment session

Other: Integrated Neuromuscular Inhibition technique

Ischemic Compression,Hotpack,TENS

ACTIVE COMPARATOR

Control group received conventional physical therapy. It included HOT Packs ( 20 minutes) , TENS (10 minutes) ,Ischemic compression .Using a pincer grasp, we identified the trigger point. Once the trigger point was identified we applied ischemic compression by placing the thumb and index finger over the active TrP. Slow, increasing levels of pressure was applied until the tissue resistance barrier was identified. Pressure was maintained until a release of the tissue barrier was felt. At that time, pressure was again applied until a new barrier was felt. This process was repeated until tension/tenderness is unable to be identified

Other: Ischemic Compression,Hotpack,TENS

Interventions

Integrated Neuromuscular inhibition technique At first ischemic compression was given using a pincer grip over the active trigger point till the tissue barrier was felt .The process was repeated till the tension reduced for 90 seconds.Ischemic compression was followed by the application of strain counterstrain. Once the position of ease was identified, it was held for 90 seconds and repeated for three to five repetitions. Muscle energy technique was applied as last part of integrated neuromuscular inhibition technique . Each isometric contraction was held for 7-10 seconds and was followed by further contralateral side bending, flexion, and ipsilateral rotation to maintain the soft tissue stretch. Each stretch was held for 30 seconds and was repeated three to five times per treatment session

Integrated Neuromuscular inhibition technique

Control group received conventional physical therapy. It included HOT Packs ( 20 minutes) , TENS (10 minutes) ,Ischemic compression .Using a pincer grasp, we identified the trigger point. Once the trigger point was identified we applied ischemic compression by placing the thumb and index finger over the active TrP. Slow, increasing levels of pressure was applied until the tissue resistance barrier was identified. Pressure was maintained until a release of the tissue barrier was felt. At that time, pressure was again applied until a new barrier was felt. This process was repeated until tension/tenderness is unable to be identified

Ischemic Compression,Hotpack,TENS

Eligibility Criteria

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

You may qualify if:

  • Patients with non specific neck pain \< 3 months duration
  • Patients who have TrPs in upper trapezius confirmed on basis of Travel and Simons diagnostic criteria

You may not qualify if:

  • Patients having any trauma
  • Signs of any serious pathology ( e.g malignancy, inflammatory disorder or fracture)
  • Signs of spinal cord compression
  • Signs of nerve root involvement
  • History of neck surgery in previous 12 months
  • History of cervical degenerative joint disease
  • Autoimmune conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iqbal Hospital

Attock, Punjab Province, 43350, Pakistan

Location

Related Publications (24)

  • Nagrale AV, Glynn P, Joshi A, Ramteke G. The efficacy of an integrated neuromuscular inhibition technique on upper trapezius trigger points in subjects with non-specific neck pain: a randomized controlled trial. J Man Manip Ther. 2010 Mar;18(1):37-43. doi: 10.1179/106698110X12595770849605.

    PMID: 21655422BACKGROUND
  • Sarigiovannis P, Hollins B. Effectiveness of manual therapy in the treatment of non-specific neck pain: a review. Physical therapy reviews. 2005;10(1):35-50.

    BACKGROUND
  • Cerezo-Tellez E, Torres-Lacomba M, Mayoral-Del-Moral O, Pacheco-da-Costa S, Prieto-Merino D, Sanchez-Sanchez B. Health related quality of life improvement in chronic non-specific neck pain: secondary analysis from a single blinded, randomized clinical trial. Health Qual Life Outcomes. 2018 Nov 6;16(1):207. doi: 10.1186/s12955-018-1032-6.

    PMID: 30400984BACKGROUND
  • Lavelle ED, Lavelle W, Smith HS. Myofascial trigger points. Anesthesiol Clin. 2007 Dec;25(4):841-51, vii-iii. doi: 10.1016/j.anclin.2007.07.003.

    PMID: 18054148BACKGROUND
  • 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
  • Vincent K, Maigne JY, Fischhoff C, Lanlo O, Dagenais S. Systematic review of manual therapies for nonspecific neck pain. Joint Bone Spine. 2013 Oct;80(5):508-15. doi: 10.1016/j.jbspin.2012.10.006. Epub 2012 Nov 16.

    PMID: 23165183BACKGROUND
  • Blikstad A, Gemmell H. Immediate effect of activator trigger point therapy and myofascial band therapy on non-specific neck pain in patients with upper trapezius trigger points compared to sham ultrasound: a randomised controlled trial. Clinical Chiropractic. 2008;11(1):23-9.

    BACKGROUND
  • Alvarez DJ, Rockwell PG. Trigger points: diagnosis and management. Am Fam Physician. 2002 Feb 15;65(4):653-60.

    PMID: 11871683BACKGROUND
  • Shah JP, Danoff JV, Desai MJ, Parikh S, Nakamura LY, Phillips TM, Gerber LH. Biochemicals associated with pain and inflammation are elevated in sites near to and remote from active myofascial trigger points. Arch Phys Med Rehabil. 2008 Jan;89(1):16-23. doi: 10.1016/j.apmr.2007.10.018.

    PMID: 18164325BACKGROUND
  • Lucas KR, Rich PA, Polus BI. Muscle activation patterns in the scapular positioning muscles during loaded scapular plane elevation: the effects of Latent Myofascial Trigger Points. Clin Biomech (Bristol). 2010 Oct;25(8):765-70. doi: 10.1016/j.clinbiomech.2010.05.006. Epub 2010 Jul 27.

    PMID: 20667633BACKGROUND
  • Hwang UJ, Kwon OY, Yi CH, Jeon HS, Weon JH, Ha SM. Predictors of upper trapezius pain with myofascial trigger points in food service workers: The STROBE study. Medicine (Baltimore). 2017 Jun;96(26):e7252. doi: 10.1097/MD.0000000000007252.

    PMID: 28658117BACKGROUND
  • Sibby GM, Kavitha Vishal S. Effectiveness of integrated neuromuscular inhibitory technique and LASER with stretching in the treatment of upper trapezius trigger points. Journal of exercise science and physiotherapy. 2009;5(2):115.

    BACKGROUND
  • Gemmell H, Allen A. Relative immediate effect of ischaemic compression and activator trigger point therapy on active upper trapezius trigger points: A randomised trial. Clinical Chiropractic. 2008;11(4):175-81.

    BACKGROUND
  • Saadat Z, Hemmati L, Pirouzi S, Ataollahi M, Ali-Mohammadi F. Effects of Integrated Neuromuscular Inhibition Technique on pain threshold and pain intensity in patients with upper trapezius trigger points. J Bodyw Mov Ther. 2018 Oct;22(4):937-940. doi: 10.1016/j.jbmt.2018.01.002. Epub 2018 Jan 17.

    PMID: 30368338BACKGROUND
  • Mehdikhani R, Okhovatian F. RETRACTED: Immediate effect of muscle energy technique on latent trigger point of upper trapezius muscle. Elsevier; 2012.

    BACKGROUND
  • Sharma A, Angusamy R, Kalra S, Singh S. Efficacy of post-isometric relaxation versus integrated neuromuscular ischaemic technique in the treatment of upper trapezius trigger points. Indian Journal of Physiotherapy and Occupational Therapy. 2010;4(3):1-5.

    BACKGROUND
  • NEELIMA A. TO ASSESS THE EFFECTIVENESS OF INTEGRATED NEURO MUSCULAR INHIBITORY TECHNIQUES (INIT) WITH STABILIZATION EXERCISES VERSUS ULTRASOUND WITH STABILIZATION EXERCISES ON UPPER TRAPEZIUS TRIGGERPOINTS IN MYOFASCIAL PAIN SYNDROME 2013.

    BACKGROUND
  • Mobilization INI. Comparison of the effect of spinal accessory nerve mobilization, integrated neuromuscular inhibition technique and conventional therapy on in upper trapezius trigger point. Quadriceps Femoris Strength Training: effect of Neuromuscular Electrical Stimulation Vs Isometric Exercise in Osteoarthritis of Knee. 2015;9(3):135.

    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
  • Bush KW, Collins N, Portman L, Tillett N. Validity and intertester reliability of cervical range of motion using inclinometer measurements. Journal of Manual & Manipulative Therapy. 2000;8(2):52-61.

    BACKGROUND
  • Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.

    PMID: 1834753BACKGROUND
  • Farooq MN, Mohseni-Bandpei MA, Gilani SA, Hafeez A. Urdu version of the neck disability index: a reliability and validity study. BMC Musculoskelet Disord. 2017 Apr 8;18(1):149. doi: 10.1186/s12891-017-1469-5.

    PMID: 28388888BACKGROUND
  • Aggarwal S, Bansal G. Efficacy of integrated neuromuscular inhibition technique in improving cervical function by reducing the trigger points on upper trapezius muscle: A randomized controlled trial. Muller Journal of Medical Sciences and Research. 2018;9(1):1-.

    BACKGROUND
  • Farina S, Casarotto M, Benelle M, Tinazzi M, Fiaschi A, Goldoni M, Smania N. A randomized controlled study on the effect of two different treatments (FREMS AND TENS) in myofascial pain syndrome. Eura Medicophys. 2004 Dec;40(4):293-301.

    PMID: 16175154BACKGROUND

MeSH Terms

Conditions

Myofascial Pain SyndromesNeck Pain

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Lal Gul Khan, MScPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Official Title: Effects of Integrated Neuromuscular Inhibition technique on upper trapezius trigger points in patients with non-specific neck pain.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2021

First Posted

August 6, 2021

Study Start

May 14, 2020

Primary Completion

December 30, 2020

Study Completion

February 26, 2021

Last Updated

August 6, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations