Effect of Manual Therapy on Sensory Features in Patients With Cervical Radiculopathy

October 28, 2017 updated by: Imam Abdulrahman Bin Faisal University

Short-term Effect of Manual Therapy on Sensory Features in Patients With Cervical Radiculopathy: A Randomized Triple-blind Experimental Study

Background & Purpose: Cervical radiculopathy is a neurological disorder, which commonly results because of nerve compression. There are different types of physical therapy interventions that are used for cervical radiculopathy. The evidence of effectiveness of manual therapy in cervical radiculopathy is still limited. Short-term hypoalgesic effects after manual therapy was found in different musculoskeletal conditions. However, the effectiveness of manual therapy in patients with cervical radiculopathy hasn't been investigated yet. Therefore, the aim of study is to examine the short-term effect of manual therapy (mobilization) on the sensory features in patients with chronic cervical radiculopathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants:

The sample size was calculated using G*power 3.1(F test, analysis of variance [ANOVA]: repeated measure, within between interaction, and a priori: compute required sample size). A result of 10 participants (treatment group=5 and sham group=5) was used to calculate the effect size (ES) of 0.44 for the pressure pain threshold on the cervical spine after the intervention(immediate effect) between group. The power estimated for ANOVA for the two group with a significance of 0.05 revealed that a total sample size of 28 participants was necessary to obtain a power of 0.80. . a minimum of 14 needed to be recruited in this study Participants with unilateral neck pain and radiating symptoms to upper extremity of more than three months were recruited from King Abdul-Aziz Hospital and East Jeddah general hospital in Jeddah, Saudia Arabia All patients signed a consent form before they participate in the study after explaining all procedures to them. The study was approved by the Institutional Review Board (IRB) at the University of Dammam (IRB Number: PGS-20160-30-142) and was approved by ministry of health at Saudia Arabia (IRB number: H-02J-002). All electronic data pertinent to the patients were being saved in a secured laptop, whereas the paper document will be kept in a locked cabinet.

Data analysis:

All statistical analysis was performed using IBM SPSS version 20 (Armonk, NY: IBM Corp). Significance levels will be set at p ≤ 0.05. Mean and standard deviation will be calculated as descriptive statistics. One-way repeated measures analysis of variance (ANOVA) and post hoc comparison, if needed will calculate the differences in the outcome measures: Quantitive sensory testing (QST), pain intensity, and active CROM

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Jeddah, Saudi Arabia
        • King AbdulAziz Hospital
      • Jeddah, Saudi Arabia
        • East jeddah general hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. unilateral neck pain and radiating to upper extremity > 3 months.
  2. age :between 35 to 65 years old.

  3. Presence 3 out of 4 positive findings:

    • spurling test.
    • distraction test,
    • upper limb neurodynamic test for median nerve
    • ipsilateral cervical rotation test less than 60 degrees.

Exclusion Criteria:

  1. osteoporosis.
  2. tumor.
  3. metabolic disease (DM,resting blood pressure are greater than 140/90).
  4. rheumatoid arthritis.
  5. history of whiplash injury.
  6. myelopathy.
  7. pregnancy.
  8. history of cervical or thoracic surgery
  9. generalized neurological disorders .
  10. leg surgery or disease (fracture) -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: manual group

  1. The Manual therapy (Mobilization):

    1. Cervical postero-anterior vertebral mobilization glides: the mobilization was grade 3 for 2 min 3 set
    2. Cervical lateral vertebral glides: the mobilization was grade 3 for 1 min 3 set.
  2. Strengthening Exercises for deep neck flexor muscle
Other: manual therapy

  1. Manual therapy: One of the following techniques was used for the treatment group based on the patients' response (i.e centralization and reduction of symptoms).

    1. Cervical postero-anterior vertebral mobilization glides:

      a central posteranterior (PA) or unilateral PA oscillatory pressure of grade III on the patient's most symptomatic level for 2 minute and 3 sets .

    2. Cervical lateral vertebral glides :at grade III for 1 minute and 3 sets.
  2. Strengthening Exercises:

for deep neck flexor muscles for 10 seconds and repeating it for 10 times.

Other Names:
  • mobilization
  • deep neck flexor exercise
SHAM_COMPARATOR: sham group
  1. Superficial soft tissue massage
  2. Strengthening Exercises: for deep neck flexor muscles for 10 seconds and repeating it for 10 times .
Other: Superficial soft tissue massage

1. Superficial soft tissue massage: The researcher applied a superficial effleurage massage without moving the deeper tissue for 2 minutes for 3 sets

Strengthening Exercises:

for deep neck flexor muscles for 10 seconds and repeating it for 10 times

Other Names:
  • deep neck flexor exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pressure pain threshold (PPT)
Time Frame: Change from baseline in PPT at immediate post intervention
An electronic algometer (Somedic AB, Farsta, Sweden) was used to quantify pain intensity (K pascal).
Change from baseline in PPT at immediate post intervention
pressure pain threshold (PPT)
Time Frame: Change from baseline in PPT at 3 weeks post intervention
An electronic algometer (Somedic AB, Farsta, Sweden) was used to quantify pain intensity (K pascal).
Change from baseline in PPT at 3 weeks post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Warmth/cold detection threshold and heat/cold pain threshold
Time Frame: Change from baseline in thermal detection & pain threshold at immediate post intervention
A Thermotest System (SenseLab - Modular Sensory Analyser, Somedic AB, Horby, Sweden) was used to determine the thermal thresholds in degrees (°C )
Change from baseline in thermal detection & pain threshold at immediate post intervention
Warmth/cold detection threshold and heat/cold pain threshold
Time Frame: Change from baseline in thermal detection & pain threshold at 3 weeks post intervention
A Thermotest System (SenseLab - Modular Sensory Analyser, Somedic AB, Horby, Sweden) was used to determine the thermal thresholds in degrees (°C )
Change from baseline in thermal detection & pain threshold at 3 weeks post intervention
The Neck Disability Index (NDI)
Time Frame: Change from baseline in NDI at immediate post intervention
The NDI is used to measure the patient reported disability in percentage
Change from baseline in NDI at immediate post intervention
The Neck Disability Index (NDI)
Time Frame: Change from baseline in NDI at 3 weeks post intervention
The NDI is used to measure the patient reported disability in percentage
Change from baseline in NDI at 3 weeks post intervention
Active Cervical Range of Motion
Time Frame: Change from baseline in CROM at immediate post intervention
Cervical range of motion (CROM) device was used to assess the cervical range of motion in degree.
Change from baseline in CROM at immediate post intervention
Active Cervical Range of Motion
Time Frame: Change from baseline in CROM at 3 weeks post intervention
Cervical range of motion (CROM) device was used to assess the cervical range of motion in degree.
Change from baseline in CROM at 3 weeks post intervention
Numerical Pain Rating Scale (NPRS)
Time Frame: Change from baseline in NPRS at immediate post intervention
The NPRS was used to assess a patient's level of pain in (11 points: 0 means no pain and 10 means severe pain.
Change from baseline in NPRS at immediate post intervention
Numerical Pain Rating Scale (NPRS)
Time Frame: Change from baseline in NPRS at 3 weeks post intervention
The NPRS was used to assess a patient's level of pain in (11 points: 0 means no pain and 10 means severe pain.
Change from baseline in NPRS at 3 weeks post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imam Abdulrahman Bin Faisal University

Investigators

  • Study Director: Ali M Alshami, Phd, Imam Abdulrahman bin Faisal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 18, 2016

Primary Completion (ACTUAL)

August 24, 2017

Study Completion (ACTUAL)

August 24, 2017

Study Registration Dates

First Submitted

October 2, 2017

First Submitted That Met QC Criteria

October 28, 2017

First Posted (ACTUAL)

November 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 1, 2017

Last Update Submitted That Met QC Criteria

October 28, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dammam University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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