Effect of Manual Therapy on Sensory Features in Patients With Cervical Radiculopathy
Primary Purpose
Cervical Radiculopathy
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
manual therapy
Superficial soft tissue massage
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Radiculopathy focused on measuring Manual therapy, cervical radiculopathy, pressure pain threshold, physiotherapy
Eligibility Criteria
Inclusion Criteria:
- unilateral neck pain and radiating to upper extremity > 3 months.
- age :between 35 to 65 years old.
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:
- osteoporosis.
- tumor.
- metabolic disease (DM,resting blood pressure are greater than 140/90).
- rheumatoid arthritis.
- history of whiplash injury.
- myelopathy.
- pregnancy.
- history of cervical or thoracic surgery
- generalized neurological disorders .
- leg surgery or disease (fracture) -
Sites / Locations
- East jeddah general hospital
- king Abdulaziz hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
manual group
sham group
Arm Description
The Manual therapy (Mobilization): Cervical postero-anterior vertebral mobilization glides: the mobilization was grade 3 for 2 min 3 set Cervical lateral vertebral glides: the mobilization was grade 3 for 1 min 3 set. Strengthening Exercises for deep neck flexor muscle
Superficial soft tissue massage Strengthening Exercises: for deep neck flexor muscles for 10 seconds and repeating it for 10 times .
Outcomes
Primary Outcome Measures
pressure pain threshold (PPT)
An electronic algometer (Somedic AB, Farsta, Sweden) was used to quantify pain intensity (K pascal).
pressure pain threshold (PPT)
An electronic algometer (Somedic AB, Farsta, Sweden) was used to quantify pain intensity (K pascal).
Secondary Outcome Measures
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 )
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 )
The Neck Disability Index (NDI)
The NDI is used to measure the patient reported disability in percentage
The Neck Disability Index (NDI)
The NDI is used to measure the patient reported disability in percentage
Active Cervical Range of Motion
Cervical range of motion (CROM) device was used to assess the cervical range of motion in degree.
Active Cervical Range of Motion
Cervical range of motion (CROM) device was used to assess the cervical range of motion in degree.
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.
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.
Full Information
NCT ID
NCT03328351
First Posted
October 2, 2017
Last Updated
October 28, 2017
Sponsor
Imam Abdulrahman Bin Faisal University
1. Study Identification
Unique Protocol Identification Number
NCT03328351
Brief Title
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
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 18, 2016 (Actual)
Primary Completion Date
August 24, 2017 (Actual)
Study Completion Date
August 24, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imam Abdulrahman Bin Faisal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy
Keywords
Manual therapy, cervical radiculopathy, pressure pain threshold, physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
manual group
Arm Type
Experimental
Arm Description
The Manual therapy (Mobilization):
Cervical postero-anterior vertebral mobilization glides: the mobilization was grade 3 for 2 min 3 set
Cervical lateral vertebral glides: the mobilization was grade 3 for 1 min 3 set.
Strengthening Exercises for deep neck flexor muscle
Arm Title
sham group
Arm Type
Sham Comparator
Arm Description
Superficial soft tissue massage
Strengthening Exercises: for deep neck flexor muscles for 10 seconds and repeating it for 10 times .
Intervention Type
Other
Intervention Name(s)
manual therapy
Other Intervention Name(s)
mobilization, deep neck flexor exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Superficial soft tissue massage
Other Intervention Name(s)
deep neck flexor exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
pressure pain threshold (PPT)
Description
An electronic algometer (Somedic AB, Farsta, Sweden) was used to quantify pain intensity (K pascal).
Time Frame
Change from baseline in PPT at immediate post intervention
Title
pressure pain threshold (PPT)
Description
An electronic algometer (Somedic AB, Farsta, Sweden) was used to quantify pain intensity (K pascal).
Time Frame
Change from baseline in PPT at 3 weeks post intervention
Secondary Outcome Measure Information:
Title
Warmth/cold detection threshold and heat/cold pain threshold
Description
A Thermotest System (SenseLab - Modular Sensory Analyser, Somedic AB, Horby, Sweden) was used to determine the thermal thresholds in degrees (°C )
Time Frame
Change from baseline in thermal detection & pain threshold at immediate post intervention
Title
Warmth/cold detection threshold and heat/cold pain threshold
Description
A Thermotest System (SenseLab - Modular Sensory Analyser, Somedic AB, Horby, Sweden) was used to determine the thermal thresholds in degrees (°C )
Time Frame
Change from baseline in thermal detection & pain threshold at 3 weeks post intervention
Title
The Neck Disability Index (NDI)
Description
The NDI is used to measure the patient reported disability in percentage
Time Frame
Change from baseline in NDI at immediate post intervention
Title
The Neck Disability Index (NDI)
Description
The NDI is used to measure the patient reported disability in percentage
Time Frame
Change from baseline in NDI at 3 weeks post intervention
Title
Active Cervical Range of Motion
Description
Cervical range of motion (CROM) device was used to assess the cervical range of motion in degree.
Time Frame
Change from baseline in CROM at immediate post intervention
Title
Active Cervical Range of Motion
Description
Cervical range of motion (CROM) device was used to assess the cervical range of motion in degree.
Time Frame
Change from baseline in CROM at 3 weeks post intervention
Title
Numerical Pain Rating Scale (NPRS)
Description
The NPRS was used to assess a patient's level of pain in (11 points: 0 means no pain and 10 means severe pain.
Time Frame
Change from baseline in NPRS at immediate post intervention
Title
Numerical Pain Rating Scale (NPRS)
Description
The NPRS was used to assess a patient's level of pain in (11 points: 0 means no pain and 10 means severe pain.
Time Frame
Change from baseline in NPRS at 3 weeks post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
unilateral neck pain and radiating to upper extremity > 3 months.
age :between 35 to 65 years old.
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:
osteoporosis.
tumor.
metabolic disease (DM,resting blood pressure are greater than 140/90).
rheumatoid arthritis.
history of whiplash injury.
myelopathy.
pregnancy.
history of cervical or thoracic surgery
generalized neurological disorders .
leg surgery or disease (fracture) -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali M Alshami, PHD
Organizational Affiliation
Imam Abdulrahman Bin Faisal University
Official's Role
Study Director
Facility Information:
Facility Name
East jeddah general hospital
City
Jeddah
Country
Saudi Arabia
Facility Name
king Abdulaziz hospital
City
Jeddah
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34663421
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.
Results Reference
derived
Learn more about this trial
Effect of Manual Therapy on Sensory Features in Patients With Cervical Radiculopathy
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