NCT04157439

Brief Summary

To compare the effect of sustain pressure and Integrated Neuromuscular Inhibition Technique on individuals with upper trapezius Trigger points (TrPs). The Study Design was Randomized control trial. According to inclusive criteria 26 patients were randomly allocated by sealed envelope method in experimental and control group. Patients were assessed at baseline and 4th day of session on NPRS, NDI questionnaire and ranges were taken by Goniometer and pressure threshold by Algometer. There was 3 drop out and the reason was loss of follow up. Hot pack was applied to both groups for 10mints before session. Sustain pressure was given for 3sec hold and 2sec release till pain decreases in control group. While, in experimental group INIT was used. Sustain pressure was applied on MTrPs for 3sec hold and 2sec release till pain decreases, Post isometric relaxation (MET) was given with 6-10 sec hold and repeat 4 times and at last Strain counter-strain (SCS) was given to hold muscle in shortest position for 90sec or pain reduced to 3 out of 10. At last cervical stretches were given and home plan was guided.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

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

September 8, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2019

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

November 6, 2019

Last Update Submit

January 8, 2020

Conditions

Keywords

Integrated Neuromuscular Inhibition TechniqueMuscle Energy TechniqueNeck Disability Index

Outcome Measures

Primary Outcomes (4)

  • Neck Disability Index (NDI)

    Changes from the baseline, NDI consist of 10 items that are pain, personal care, lifting, headache, recreation work, driving, concentration, sleeping and reading. It is completed by patient related to different functional status. NDI is used with musculoskeletal (MSK) related neck pain, cervical radiculopathy and other cervical related problems. Each item is rated by choosing one of five response categories and transformed to a total score from 0 to 100 (worst possible).

    4th day

  • Numeric Pain Rating Scale (NPRS)

    Changes from the baseline, Numeric pain rating scale is used to measure the intensity of pain. Numeric pain rating scale is like Visual analogue scale, in which a straight line is drawn to tell the intensity of pain.1 to 10 is the range of NPRS in which 0 means no pain and 10 means the worst pain ever. The scoring is easy at NPRS and requires at least minimum of 1 minute to end.

    4th day

  • Algometer

    Changes from the Baseline, Algometer is a device for determining sensitiveness to pain caused by pressure. Pressure algometry is a valuable and reliable instrument in the assessment of MTrPs sensitivity. It has been used successfully for the evaluation of Myofascial Trigger Points (MTrPs), to confirm the diagnosis, and to quantify irritability. Therapeutic effectiveness of various procedures on MTrPs can be quantified by algometry

    4th day

  • Goniometer:

    Changes from the baseline, To measure the cervical Range of Motion (ROM's) a large plastic called Goniometer is used worldwide. In different clinical settings to measure ranges of extremities and spine Goniometer is used. For measuring cervical ROMs patient sits in upright posture with thoracic and lumbar spine stable with the chair. Knees and hip are at angle of 90/90 and feet stable on floor and arms on the sides of chair. Then patient is said to move the head in either positions as far as possible. Movements include extension, flexion, right or left side bending and rotation

    4th day

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Hot fermentation, Sustain pressure on trigger point, Self-stretches

Other: Control Group

Experimental Group

EXPERIMENTAL

Integrated Neuromuscular Inhibition Technique Post isometric stretch (MET) Strain counter strain

Other: Experimental Group

Interventions

Hot fermentation was applied for 10 mints Sustain pressure on trigger point was applied with thumb for 3secs hold and 2 sec release (till pain is reduced). Self-stretches of cervical muscles (10 reps× 1set) For home plan cervical muscles stretching and postural care was guided

Control Group

Hot fermentation was applied for 10 mints. Integrated Neuromuscular Inhibition Technique \[sustain pressure, Post Isometric Relaxation (PIR) and SCS\]. Sustain pressure was applied on trigger points using thumb for 3 sec hold and 2 mints release (till pain is reduced). Post isometric stretch (MET) was given with 4 repetitions (6-10sec hold). Strain counter strain was given in which upper trapezius shortened position was maintained by slight flexion, same side bending, opposite rotation and shoulder abduction for 90 sec and repeats this procedure till the pain is reduced to 3 out of 10. Self-stretches for cervical muscles were done at the end of session to maintain the gained ranges (10 reps×1 set) For home plan cervical muscles stretching and postural care was guided

Experimental Group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Limited range of motion (ROM): side bending or rotation (any side)
  • Pain more than 3 on NPRS
  • Upper trapezius triggers points: any one

You may not qualify if:

  • Radiculopathies
  • Malignancy
  • Infection
  • Trauma
  • Positive vertebrobasilar insufficiency (VBI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International university

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (9)

  • Chiarotto A, Clijsen R, Fernandez-de-Las-Penas C, Barbero M. Prevalence of Myofascial Trigger Points in Spinal Disorders: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2016 Feb;97(2):316-37. doi: 10.1016/j.apmr.2015.09.021. Epub 2015 Oct 17.

    PMID: 26475933BACKGROUND
  • Vazquez-Delgado E, Cascos-Romero J, Gay-Escoda C. Myofascial pain syndrome associated with trigger points: a literature review. (I): Epidemiology, clinical treatment and etiopathogeny. Med Oral Patol Oral Cir Bucal. 2009 Oct 1;14(10):e494-8. doi: 10.4317/medoral.14.e494.

    PMID: 19680218BACKGROUND
  • Fernandez-de-Las-Penas C, Simons D, Cuadrado ML, Pareja J. The role of myofascial trigger points in musculoskeletal pain syndromes of the head and neck. Curr Pain Headache Rep. 2007 Oct;11(5):365-72. doi: 10.1007/s11916-007-0219-z.

    PMID: 17894927BACKGROUND
  • simons DG. Understanding effective treatments of myofascial trigger points. Journal of Bodywork and movement therapies. 2002;6(2):81-8.

    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
  • Ravichandran P, Ponni HK, Aseer PAL. Effectiveness of ischemic compression on trapezius myofascial trigger points in neck pain. International Journal of Physiotherapy. 2016;3(2):186-92.

    BACKGROUND
  • Lenehan KL, Fryer G, McLaughlin P. The effect of muscle energy technique on gross trunk range of motion. Journal of osteopathic medicine. 2003;6(1):13-8.

    BACKGROUND
  • Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

    PMID: 22588748BACKGROUND
  • Hong C-Z. Algometry in evaluation of trigger points and referred pain. Journal of Musculoskeletal Pain. 1998;6(1):47-59.

    BACKGROUND

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Abdul Ghafoor Sajjad, Phd*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 6, 2019

First Posted

November 8, 2019

Study Start

September 8, 2018

Primary Completion

December 10, 2018

Study Completion

February 28, 2019

Last Updated

January 10, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations