Effects of Thoracic Screw Manipulation in Patients With Cervical Radiculopathy

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05749835
Collaborator
(none)
44
1
2
18.1
2.4

Study Details

Study Description

Brief Summary

Cervical radiculopathy is a pain and/or sensorimotor deficit syndrome that is defined as being caused by compression of a cervical nerve root. The compression can occur as a result of disc herniation, Spondylosis, instability, trauma, or rarely, tumors.

Thoracic spine manipulation (TSM) is defined as a high-velocity/low amplitude movement or "thrust" directed at any segment of the thoracic spine. Recent research has shown that Thoracic Joint Manipulation directed to the thoracic spine provides a therapeutic benefit to patients with neck pain and has been suggested as an appropriate strategy to minimize the risks associated with manipulation of the cervical spine

Condition or Disease Intervention/Treatment Phase
  • Other: Thoracic Manipulation and Sustained Natural Apophyseal Glides and conventional therapy
  • Other: Sustained Natural Apophyseal Glides and conventional therapy
N/A

Detailed Description

Patient presentations can range from complaints of pain, numbness, and/or tingling in the upper extremity to electrical type pains or even weakness. (3) Disc herniation accounts for 20-25% of the cases of cervical radiculopathy. (4)Most of the time cervical radiculopathy appears unilaterally; however it is possible for bilateral symptoms to be present if severe bony spurs are present at one level, impinging/irritating the nerve root on both sides. If peripheral radiation of pain, weakness, or pins and needle are present, the location of the pain will follow back to the concerned affected nerve root Manual techniques include positional release technique, muscle energy technique, myofascial release technique, Cyriax technique, Natural Apophyseal Glides and Sustained Natural Apophyseal Glides, manual pressure release, proprioceptive neuromuscular facilitation and ischemic compression.

Thoracic spine manipulation (TSM) is defined as a high-velocity/low amplitude movement or "thrust" directed at any segment of the thoracic spine. Recent research has shown that Thoracic Joint Manipulation directed to the thoracic spine provides a therapeutic benefit to patients with neck pain and has been suggested as an appropriate strategy to minimize the risks associated with manipulation of the cervical spine

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Thoracic Screw Manipulation in Patients With Cervical Radiculopathy
Actual Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 5, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Thoracic Manipulation and Sustained Natural Apophyseal Glides and conventional therapy

After the segmental mobility examination of thoracic spine, the therapist will apply a high-velocity, end range screw thrust to a restricted segment of the thoracic spine as described by Maitland et al

Other: Thoracic Manipulation and Sustained Natural Apophyseal Glides and conventional therapy
After the segmental mobility examination of thoracic spine, the therapist will apply a high-velocity, end range screw thrust to a restricted segment of the thoracic spine as described by Maitland.

Experimental: Sustained Natural Apophyseal Glides and conventional therapy

Position of therapist: stands beside the patient, while his\her head is cradled between your body and your right forearm (when you stand at his\her right side). Gentle pressure is now applied in a ventral direction on the spinous process of C7 while the skull remains still due to the control of your right forearm. (The really gentle moving force to do this comes from your left arm via the thenar eminence over the little finger on the spine of C7).

Other: Sustained Natural Apophyseal Glides and conventional therapy
Position of therapist: stands beside the patient, while his\her head is cradled between your body and your right forearm (when you stand at his\her right side). Gentle pressure is now applied in a ventral direction on the spinous process of C7 while the skull remains still due to the control of your right forearm. (The really gentle moving force to do this comes from your left arm via the thenar eminence over the little finger on the spine of C7).

Outcome Measures

Primary Outcome Measures

  1. NPRS (Numeric Pain Rating Scale). [four weeks]

    The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale from 0 to 10. "0" = no pain and "10" = the most intense pain imaginable.

  2. Inclinometer [four weeks]

    ICCs ranging from .89 to .94

  3. (Neck Disability Index) Urdu [four weeks]

    the neck disability index is a ten-item self-reported Questionnaire that assesses pain and associated disability, with a total max score of 50 points. An Urdu version of neck disability index will be used in this study. The total scores (ICC = 0.99) of the Neck Disability Index -Urdu.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Patients complaint from pain in the cervical spine and pain or paresthesia traveling from the neck into a specific region of the arm, forearm or hand Cervical Lateral flexion and rotation <60 degree Positive scores on 3 of 4 clinical tests: Spurling's test, upper-limb neurodynamic test/median nerve bias, cervical distraction test, and cervical rotation toward the symptomatic side of less than 60° Hypomobility at T1- T5 thoracic vertebrae on springing test.

Exclusion Criteria:

Participants with a history of vertebro-basilary artery insufficiency. Patient with history of cervical surgery or arthroplasty Patients with a positive history of trauma, fracture or surgery of the cervical spine Diagnosed cases of Torticollis, and scoliosis History of osteoporosis, Any heart disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 Railway General Hospital Rawalpindi Punjab Pakistan

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: maria Khalid, MSOMPT, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05749835
Other Study ID Numbers:
  • REC/Letter- 01392
First Posted:
Mar 1, 2023
Last Update Posted:
Mar 1, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 1, 2023