NCT03652831

Brief Summary

This study will evaluate effect of soft tissue mobilization with and with out neural mobilization in cervical radiculopathy, half of the subjects will receive treatment of soft tissue mobilization along with neural mobilization whereas half of the subjects will receive only soft tissue mobilization.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Status
unknown

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, 2018

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

6 months

First QC Date

August 27, 2018

Last Update Submit

August 28, 2018

Conditions

Keywords

Cervical radiculopathy,Soft tissue mobilization,Neural mobilization

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Pain intensity in one of the upper limb is measured by Numeric pain scale in which "0" shows No pain while "10" shows worst pain.

    4weeks

Secondary Outcomes (2)

  • Recurrence of pain and Neck disability

    4weeks

  • Neck Range of Motion

    4weeks

Study Arms (2)

Soft Tissues mobilization with Neural mobilization

ACTIVE COMPARATOR

Soft Tissue Mobilization with Neural mobilization group will be assessed by spurling test and than will involved in treatment protocol i.e Cervical Traction, Hot packs, Post Isometric Relaxation Techniques and Neural mobilization Techniques which involve Median, Radial and Ulnar Nerve Mobilization. Frequency for neural mobilization is 3 sets of 10 repetitions for each and duration of 15minute. Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 50mints each session)

Other: Soft Tissue Mobilization with Neural Mobilization

Soft Tissues mobilization without Neural mobilization

ACTIVE COMPARATOR

Soft Tissue Mobilization with Neural mobilization group will be assessed by spurling test and than will involved in treatment protocol i.e Cervical Traction, Hot packs, Post Isometric Relaxation Techniques. Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 35mints each session)

Other: Soft Tissue Mobilization without Neural Mobilization

Interventions

Cervical Traction for 15mints 7%of body weight with 7 second hold time and 5 second rest time. * Hot Pack for 10mints * Post isometric relaxation technique. The post-isometric relaxation technique begins by placing the muscle in a stretched position. Then an isometric contraction is exerted against minimal resistance. Relaxation and then gentle stretch follow as the muscle releases. Frequency for PIRs 3sets of 5 repetitions and duration of 10minute. * Neural mobilization technique includes Median, Radial and Ulnar nerve mobilization. Frequency for neural mobilization is 3 sets of 10 repetitions for each and duration of 15minute. Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 50mints each session)

Soft Tissues mobilization with Neural mobilization

* Cervical Traction for 15mints 7%of body weight with 7 second hold time and 5 second rest time. * Hot Pack for 10mints * Post isometric relaxation technique. The post-isometric relaxation technique begins by placing the muscle in a stretched position. Then an isometric contraction is exerted against minimal resistance. Relaxation and then gentle stretch follow as the muscle releases. Frequency for PIRs 3sets of 5 repetitions and duration of 10minutes Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 35mints each session)

Soft Tissues mobilization without Neural mobilization

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with age 18 to 55years
  • Patients having pain more than 3months
  • Radiating pain in one of the upper limb
  • Spurling's test positive

You may not qualify if:

  • Traumatic injury of upper limb or cervical spine
  • Vertebral artery test positive(dizziness, vomiting, diplopia, drop attacks etc)
  • Patient asymptomatic for pain but symptomatic for tingling and paraesthesia
  • Circulatory disturbance of upper extremity
  • Known history of high level of spinal cord injury and malignancy
  • Thoracic Outlet syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Noor Ul Ain, Mphil-OPT

CONTACT

Waqar Ahmed Awan, Ph D Rehab

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Subjects will be assigned randomly into two groups: Soft tissue mobilization with neural mobilization and Soft tissue mobilization without Neural mobilization.A coin will be flipped at start of data collection for the first patient to be assigned odd number and included in Soft tissue mobilization with Neural mobilization group. Later on odd and even numbered subjects will be included in specific group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

August 27, 2018

First Posted

August 29, 2018

Study Start

August 1, 2018

Primary Completion

February 1, 2019

Study Completion

March 1, 2019

Last Updated

August 29, 2018

Record last verified: 2018-08