NCT04179214

Brief Summary

This study intends to determine the effects of thoracic manipulation on pressure pain sensitivity in patients with rhomboid active trigger points.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

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

July 22, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

January 3, 2020

Status Verified

January 1, 2020

Enrollment Period

5 months

First QC Date

November 25, 2019

Last Update Submit

January 1, 2020

Conditions

Keywords

Trigger Area

Outcome Measures

Primary Outcomes (6)

  • Numeric pain rating scale (NPRS)

    Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline and after 3 weeks

    Baseline

  • Numeric pain rating scale (NPRS)

    Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline and after 3 weeks

    post 3 weeks

  • Pain pressure threshold

    It is measured with the help of an instrument called Algometer. The readings of Algometer are both in pounds and kilograms and it gauges the pressure at which patient feels pain.

    baseline

  • Pain pressure threshold

    It is measured with the help of an instrument called Algometer. The readings of Algometer are both in pounds and kilograms and it gauges the pressure at which patient feels pain.

    post 3 weeks

  • Thoracic ROM

    A thoraxic range of motion (TROM) inclinometer will be use to assess thoracic range of motion in flexion and extension.. Participants will be seated or standing upright and asked to actively move their trunk in forward and backward direction

    Baseline

  • Thoracic ROM

    A thoraxic range of motion (TROM) inclinometer will be use to assess thoracic range of motion in flexion and extension.. Participants will be seated or standing upright and asked to actively move their trunk in forward and backward direction

    post 3 weeks

Secondary Outcomes (2)

  • Neck Disability Index (NDI)

    Baseline

  • Neck Disability Index (NDI)

    post 3 weeks

Study Arms (2)

Group I Experimental: thoracic manipulation

EXPERIMENTAL

The experimental group will receive thoracic manipulation along with conventional pt protocol.

Other: Thoracic manipulation

Group II Control

ACTIVE COMPARATOR

this group of participant will receive Conventional physical therapy protocol

Other: conventional pt protocol

Interventions

Session will be performed twice a week for a three week period if a pop sound occurred then the therapist moved on next procedure ,if not subject will be repositioned and technique will performed again. This procedure will be performed for maximum of two attempts. Approximately 3 minutes of time is required to complete thrust manipulation subjects assigned to thrust manipulation also received general exercise program and manual pressure release technique as the control group. General exercise group involve Stretching exercises for the pectoral muscles and resisted strengthening exercises for the scapular retractors and elevators and the glenohumeral abductors and external rotators were performed three times per week for 3 weeks.

Group I Experimental: thoracic manipulation

This group will receive manual pressure release technique along with general exercises program. General exercise group involve Stretching exercises for the pectoral muscles and resisted strengthening exercises for the scapular retractors and elevators and the glenohumeral abductors and external rotators were performed three times per week for 3 weeks.

Group II Control

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 to 30 years
  • Participants presented with interscapular pain
  • Forward head posture with active trigger points in rhomboid muscle
  • Segmental hypomobility in upper thoracic identified with positive springing test

You may not qualify if:

  • Participants who demonstrated contraindication to manipulation
  • Open wounds or Trauma to the area which occurred less than two months prior treatment
  • Any neurological compromise
  • Mid scapular pain due to degenerative process or osteoporosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women Institute of Rehabilitation Sciences

Abbottabad, KPK, 22010, Pakistan

Location

Related Publications (6)

  • Schiller L. Effectiveness of spinal manipulative therapy in the treatment of mechanical thoracic spine pain: a pilot randomized clinical trial. J Manipulative Physiol Ther. 2001 Jul-Aug;24(6):394-401. doi: 10.1067/mmt.2001.116420.

    PMID: 11514816BACKGROUND
  • Ruiz-Saez M, Fernandez-de-las-Penas C, Blanco CR, Martinez-Segura R, Garcia-Leon R. Changes in pressure pain sensitivity in latent myofascial trigger points in the upper trapezius muscle after a cervical spine manipulation in pain-free subjects. J Manipulative Physiol Ther. 2007 Oct;30(8):578-83. doi: 10.1016/j.jmpt.2007.07.014.

    PMID: 17996549BACKGROUND
  • Dunning JR, Cleland JA, Waldrop MA, Arnot CF, Young IA, Turner M, Sigurdsson G. Upper cervical and upper thoracic thrust manipulation versus nonthrust mobilization in patients with mechanical neck pain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):5-18. doi: 10.2519/jospt.2012.3894. Epub 2011 Sep 30.

    PMID: 21979312BACKGROUND
  • Nilsson N, Christensen HW, Hartvigsen J. The effect of spinal manipulation in the treatment of cervicogenic headache. J Manipulative Physiol Ther. 1997 Jun;20(5):326-30.

    PMID: 9200048BACKGROUND
  • Cleland JA, Glynn P, Whitman JM, Eberhart SL, MacDonald C, Childs JD. Short-term effects of thrust versus nonthrust mobilization/manipulation directed at the thoracic spine in patients with neck pain: a randomized clinical trial. Phys Ther. 2007 Apr;87(4):431-40. doi: 10.2522/ptj.20060217. Epub 2007 Mar 6.

    PMID: 17341509BACKGROUND
  • Haleema B, Riaz H. Effects of thoracic spine manipulation on pressure pain sensitivity of rhomboid muscle active trigger points: A randomized controlled trial. J Pak Med Assoc. 2021 Jul;71(7):1720-1724. doi: 10.47391/JPMA.02-256.

Study Officials

  • Huma Riaz, PHD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This study will be single blinded randomized control trail, participants will be unaware of treatment groups, they will be randomly allocated through sealed envelope method.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Both experimental and control groups will be treated simultaneously with one treatment option common to both groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2019

First Posted

November 27, 2019

Study Start

July 22, 2019

Primary Completion

December 15, 2019

Study Completion

December 30, 2019

Last Updated

January 3, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations