Trials / Completed
CompletedNCT03328351
Effect of Manual Therapy on Sensory Features in Patients With Cervical Radiculopathy
Short-term Effect of Manual Therapy on Sensory Features in Patients With Cervical Radiculopathy: A Randomized Triple-blind Experimental Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Imam Abdulrahman Bin Faisal University · Academic / Other
- Sex
- All
- Age
- 35 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 | 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 |
Timeline
- Start date
- 2016-12-18
- Primary completion
- 2017-08-24
- Completion
- 2017-08-24
- First posted
- 2017-11-01
- Last updated
- 2017-11-01
Locations
2 sites across 1 country: Saudi Arabia
Source: ClinicalTrials.gov record NCT03328351. Inclusion in this directory is not an endorsement.