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

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ClinicalTrials.gov Identifier: NCT03328351
Recruitment Status : Completed
First Posted : November 1, 2017
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
Dammam University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cervical Radiculopathy Other: manual therapy Other: Superficial soft tissue massage Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: triple-blind (The researcher was blinded to the outcome measures, whereas the assessor, who performed the outcome measures was blinded to the patient groups. The patient was blinded to treatment)
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short-term Effect of Manual Therapy on Sensory Features in Patients With Cervical Radiculopathy: A Randomized Triple-blind Experimental Study
Actual Study Start Date : December 18, 2016
Actual Primary Completion Date : August 24, 2017
Actual Study Completion Date : August 24, 2017

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 Name: deep neck flexor exercise




Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. 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 )

  2. 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 )

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.



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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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) -

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): NCT03328351


Locations
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Saudi Arabia
East jeddah general hospital
Jeddah, Saudi Arabia
king Abdulaziz hospital
Jeddah, Saudi Arabia
Sponsors and Collaborators
Dammam University
Investigators
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Study Director: Ali M Alshami, PHD Imam Abdulrahman Bin Faisal University

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Responsible Party: Dammam University
ClinicalTrials.gov Identifier: NCT03328351     History of Changes
Other Study ID Numbers: Dammam University
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Dammam University:
Manual therapy
cervical radiculopathy
pressure pain threshold
physiotherapy

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