Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-02-21 @ 7:23 PM
Study NCT ID:
NCT03328351
Status:
COMPLETED
Last Update Posted:
2017-11-01
First Post:
2017-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Manual Therapy on Sensory Features in Patients With Cervical Radiculopathy
Sponsor:
Imam Abdulrahman Bin Faisal University
Organization:
Study Overview
Official Title:
Short-term Effect of Manual Therapy on Sensory Features in Patients With Cervical Radiculopathy: A Randomized Triple-blind Experimental Study
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: