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Effect of Soft Tissue Mobilization With and Without Neural Mobilization in Cervical Radiculopathy

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ClinicalTrials.gov Identifier: NCT03652831
Recruitment Status : Not yet recruiting
First Posted : August 29, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Noor Abid, Isra University

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.

Condition or disease Intervention/treatment Phase
Cervical Radiculopathy Other: Soft Tissue Mobilization with Neural Mobilization Other: Soft Tissue Mobilization without Neural Mobilization Not Applicable

Detailed Description:

soft tissue mobilization and neural mobilization both treatments are used to treat cervical radiculopathy but they work differently.

Soft tissue mobilization include traction which decompresses the nerve and stretches the surrounding muscles along with help to reduce pain and tingling sensation. whereas hot pack helps to increase blood circulation and warm up muscles and isometric exercises provide strengthening and build endurance.

Neural mobilization technique is different for all 3 nerves i.e Radial, ulnar and median. neural mobilization technique target the single nerve which is being compressed and showing symptoms.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Soft Tissue Mobilization With and Without Neural Mobilization in Cervical Radiculopathy
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : March 2019

Arm Intervention/treatment
Active Comparator: Soft Tissues mobilization with Neural mobilization

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

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)


Active Comparator: Soft Tissues mobilization without Neural mobilization

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
  • 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)




Primary Outcome Measures :
  1. Pain intensity [ Time Frame: 4weeks ]
    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.


Secondary Outcome Measures :
  1. Recurrence of pain and Neck disability [ Time Frame: 4weeks ]
    Neck disability index scale used to measure ability to manage neck pain in everyday life in terms of: Pain intensity, Personal care, Lifting, Reading, Headaches, and Concentration. In which "0" shows disability and "5" shows normal.

  2. Neck Range of Motion [ Time Frame: 4weeks ]
    Range of motion of the cervical spine and upper extremity (any of the upper limb) measured by Goniometer. Values deviated from standard values are considered as abnormal. The DASH Outcome Measure is scored as: the disability/symptom section (30 items, scored 1-5) where "1" shows No difficulty and "5" shows maximal difficulty



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652831


Contacts
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Contact: Noor Ul Ain, Mphil-OPT 0333-5292822 Noorabid2015@gmail.com
Contact: Waqar Ahmed Awan, Ph D Rehab 03335348846 wawan01@hotmail.com

Sponsors and Collaborators
Isra University

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Responsible Party: Noor Abid, Research Associate, Isra University
ClinicalTrials.gov Identifier: NCT03652831     History of Changes
Other Study ID Numbers: IIRS-IUISB/Mphil/002
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Noor Abid, Isra University:
Cervical radiculopathy,
Soft tissue mobilization,
Neural mobilization

Additional relevant MeSH terms:
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Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases