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

Imam Abdulrahman Bin Faisal University

Status: Completed

Conditions: Cervical Radiculopathy

Treatments: Other: manual therapy; Other: Superficial soft tissue massage

Study type: Interventional

Funder types: Other

Identifiers

NCT03328351

Dammam University

Details and patient eligibility

About

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.

Full 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

Enrollment: 28 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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) -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

manual group

Experimental group

Description:

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

Treatment:

Other: manual therapy

sham group

Sham Comparator group

Description:

1. Superficial soft tissue massage 2. Strengthening Exercises: for deep neck flexor muscles for 10 seconds and repeating it for 10 times .

Treatment:

Other: Superficial soft tissue massage