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

Not Applicable

Completed

• Conditions: Cervical Radiculopathy
• Interventions: Other: manual therapy; Other: Superficial soft tissue massage

• Registration Number: NCT03328351
• Lead Sponsor: Imam Abdulrahman Bin Faisal 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.

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 Timeline

• Study Start: 2016-12-18
• Primary Completion: 2017-08-24
• Study Completion: 2017-08-24
• Status Verified: 2017-10
• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-10-28
• Last Update Submitted: 2017-10-28
• Study First Posted: 2017-11-01
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
manual group	manual therapy	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
sham group	Superficial soft tissue massage	1. Superficial soft tissue massage 2. Strengthening Exercises: for deep neck flexor muscles for 10 seconds and repeating it for 10 times .

Primary Outcome Measures

Name	Time	Method
pressure pain threshold (PPT)	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

Name	Time	Method
The Neck Disability Index (NDI)	Change from baseline in NDI at 3 weeks post intervention	The NDI is used to measure the patient reported disability in percentage
Active Cervical Range of Motion	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.
Warmth/cold detection threshold and heat/cold pain threshold	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 )
Numerical Pain Rating Scale (NPRS)	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.

Trial Locations

Locations (2)

East jeddah general hospital; 🇸🇦 Jeddah, Saudi Arabia

king Abdulaziz hospital; 🇸🇦 Jeddah, Saudi Arabia