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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Cervical Radiculopathy

Intervention / Treatment
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* Other: manual therapy
* Other: Superficial soft tissue massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral neck pain and radiating to upper extremity > 3 months. age :between 35 to 65 years old. 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: osteoporosis. tumor. metabolic disease (DM,resting blood pressure are greater than 140/90). rheumatoid arthritis. history of whiplash injury. myelopathy. pregnancy. history of cervical or thoracic surgery generalized neurological disorders . leg surgery or disease (fracture) -

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: manual group<br>The Manual therapy (Mobilization): Cervical postero-anterior vertebral mobilization glides: the mobilization was grade 3 for 2 min 3 set Cervical lateral vertebral glides: the mobilization was grade 3 for 1 min 3 set. Strengthening Exercises for deep neck flexor muscle | Other: manual therapy<br>* 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). 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 . Cervical lateral vertebral glides :at grade III for 1 minute and 3 sets. Strengthening Exercises: for deep neck flexor muscles for 10 seconds and repeating it for 10 times.<br>* Other names: deep neck flexor exercise;|
| Sham Comparator: sham group<br>Superficial soft tissue massage Strengthening Exercises: for deep neck flexor muscles for 10 seconds and repeating it for 10 times . | Other: Superficial soft tissue massage<br>* 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<br>* Other names: deep neck flexor exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pressure pain threshold (PPT) | 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) | 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 | 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 | 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) | 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) | 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 | 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 | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Manual therapy, cervical radiculopathy, pressure pain threshold, physiotherapy