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

Cervical Radiculopathy Clinical Trial

Official title:

Short-term Effect of Manual Therapy on Sensory Features in Patients With Cervical Radiculopathy: A Randomized Triple-blind Experimental Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03328351
• Other study ID #: Dammam University
• Status: Completed
• Phase: N/A
• First received: October 2, 2017
• Last updated: October 28, 2017
• Start date: December 18, 2016
• Est. completion date: August 24, 2017

Study information

• Verified date: October 2017
• Source: Dammam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 24, 2017
• Est. primary completion date: August 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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) -

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy

Intervention

Other:
• manual therapy
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). 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 . Cervical lateral vertebral glides :at grade III for 1 minute and 3 sets. Strengthening Exercises: for deep neck flexor muscles for 10 seconds and repeating it for 10 times.
• 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

Locations

Country	Name	City	State
Saudi Arabia	East jeddah general hospital	Jeddah
Saudi Arabia	king Abdulaziz hospital	Jeddah

Sponsors (1)

Lead Sponsor	Collaborator
Dammam University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pressure pain threshold (PPT)	An electronic algometer (Somedic AB, Farsta, Sweden) was used to quantify pain intensity (K pascal).	Change from baseline in PPT at immediate post intervention
Primary	pressure pain threshold (PPT)	An electronic algometer (Somedic AB, Farsta, Sweden) was used to quantify pain intensity (K pascal).	Change from baseline in PPT at 3 weeks post intervention
Secondary	Warmth/cold detection threshold and heat/cold pain threshold	A Thermotest System (SenseLab - Modular Sensory Analyser, Somedic AB, Horby, Sweden) was used to determine the thermal thresholds in degrees (°C )	Change from baseline in thermal detection & pain threshold at immediate post intervention
Secondary	Warmth/cold detection threshold and heat/cold pain threshold	A Thermotest System (SenseLab - Modular Sensory Analyser, Somedic AB, Horby, Sweden) was used to determine the thermal thresholds in degrees (°C )	Change from baseline in thermal detection & pain threshold at 3 weeks post intervention
Secondary	The Neck Disability Index (NDI)	The NDI is used to measure the patient reported disability in percentage	Change from baseline in NDI at immediate post intervention
Secondary	The Neck Disability Index (NDI)	The NDI is used to measure the patient reported disability in percentage	Change from baseline in NDI at 3 weeks post intervention
Secondary	Active Cervical Range of Motion	Cervical range of motion (CROM) device was used to assess the cervical range of motion in degree.	Change from baseline in CROM at immediate post intervention
Secondary	Active Cervical Range of Motion	Cervical range of motion (CROM) device was used to assess the cervical range of motion in degree.	Change from baseline in CROM at 3 weeks post intervention
Secondary	Numerical Pain Rating Scale (NPRS)	The NPRS was used to assess a patient's level of pain in (11 points: 0 means no pain and 10 means severe pain.	Change from baseline in NPRS at immediate post intervention
Secondary	Numerical Pain Rating Scale (NPRS)	The NPRS was used to assess a patient's level of pain in (11 points: 0 means no pain and 10 means severe pain.	Change from baseline in NPRS at 3 weeks post intervention