NCT05582733

Brief Summary

To determine the immediate effects of cervical spine manipulation on pressure pain sensitivity on upper trapezius trigger point. it was a randomized control trial including 66 patients at physiotherapy OPD of railway rehabilitation center from August 2019 to December 2019, Railway General Hospital Pakistan and Max Rehab and decompression center Max health Hospital G8 Islamabad. The subjects were randomly divided into two groups (group control and experimental) by free envelope method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2020

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
Last Updated

October 17, 2022

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

October 3, 2022

Last Update Submit

October 12, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • changes from the baseline in Algometer values

    It is a device used to identify the pressure and force eliciting a pressure pain threshold. The hand held algometer 1 cm round rubber surface which applies force and display for readings in newtons or kilograms.Sustained force is usually applied at the right angle to the soft tissue. Estimated pressure application rates have ranged from 0.05 to 20N/s. it has a high validity and reliability for measuring pain pressure threshold in patients of myofascial trigger points.

    Baseline and 3 weeks

  • changes from the baseline in Inclinometer values

    It is a device used to measure neck ranges of motion.

    Baseline and 3 weeks

Study Arms (2)

Cervical spine manipulation

EXPERIMENTAL

In spinal manipulation, the velocity, magnitude and direction of the impulse are controlled to encourage relaxation and comfort of muscle and connective tissue.

Other: Cervical spine manipulationOther: traction

traction

EXPERIMENTAL

aimed to relieve pressure on the spine

Other: Cervical spine manipulationOther: traction

Interventions

hot pack for 10 minutes will be applied followed by cervical manipulation (chin hold kaltenborn) once and then stretching

Cervical spine manipulationtraction

Hot pack will be applied followed by sustained pressure or MPR for 90 sec and then stretching.

Cervical spine manipulationtraction

Eligibility Criteria

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

You may qualify if:

  • presence MTrps in upper trapezius
  • limited side bending and rotation
  • both gender
  • age between 25 to 45

You may not qualify if:

  • Malignancy, infection, trauma, bone deformities.
  • Acute Disc Protrusion
  • Positive VBI
  • Positive Sharp purser test
  • History of whiplash injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Abdul Gaffoor

Islamabad, 00430, Pakistan

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Traction

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresSurgical Procedures, Operative

Study Officials

  • Abdul Ghafoor Sajjad, PHD*

    ghafoor.sajjad@riphah.edu.pk

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Free envelop method
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Control was treated with Manual Pressure release followed by stretching while in experimental received cervical spine manipulation (chin hold) kaltenborn followed by stretching.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 3, 2022

First Posted

October 17, 2022

Study Start

August 1, 2019

Primary Completion

December 30, 2019

Study Completion

January 28, 2020

Last Updated

October 17, 2022

Record last verified: 2022-10

Locations