Clinical trial NCT03328351: Effect of Manual Therapy on Sensory Features in Patients With Cervical Radiculopathy
Official title: Short-term Effect of Manual Therapy on Sensory Features in Patients With Cervical Radiculopathy: A Randomized Triple-blind Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Radiculopathy
Keywords: Manual therapy
cervical radiculopathy
pressure pain threshold
physiotherapy
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 28
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: TREATMENT

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

Eligibility criteria: 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) -

Primary outcomes:
measure: pressure pain threshold (PPT)
timeFrame: Change from baseline in PPT at immediate post intervention
measure: pressure pain threshold (PPT)
timeFrame: Change from baseline in PPT at 3 weeks post intervention
Secondary outcomes:
measure: Warmth/cold detection threshold and heat/cold pain threshold
timeFrame: Change from baseline in thermal detection & pain threshold at immediate post intervention
measure: Warmth/cold detection threshold and heat/cold pain threshold
timeFrame: Change from baseline in thermal detection & pain threshold at 3 weeks post intervention
measure: The Neck Disability Index (NDI)
timeFrame: Change from baseline in NDI at immediate post intervention
measure: The Neck Disability Index (NDI)
timeFrame: Change from baseline in NDI at 3 weeks post intervention
measure: Active Cervical Range of Motion
timeFrame: Change from baseline in CROM at immediate post intervention
measure: Active Cervical Range of Motion
timeFrame: Change from baseline in CROM at 3 weeks post intervention
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: Change from baseline in NPRS at immediate post intervention
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: Change from baseline in NPRS at 3 weeks post intervention
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: East jeddah general hospital
city: Jeddah
country: Saudi Arabia
facility: king Abdulaziz hospital
Study officials:
affiliation: Imam Abdulrahman Bin Faisal University
name: Ali M Alshami, PHD
role: STUDY_DIRECTOR
References:
citation: Alshami AM, Bamhair DA. Effect of manual therapy with exercise in patients with chronic cervical radiculopathy: a randomized clinical trial. Trials. 2021 Oct 18;22(1):716. doi: 10.1186/s13063-021-05690-y.