Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| manual group | Experimental |
|
|
| sham group | Sham Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| manual therapy | Other |
for deep neck flexor muscles for 10 seconds and repeating it for 10 times. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Warmth/cold detection threshold and heat/cold pain threshold |
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ali M Alshami, PHD | Imam Abdulrahman Bin Faisal University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East jeddah general hospital | Jeddah | Saudi Arabia | ||||
| king Abdulaziz hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34663421 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
Not provided
Not provided
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)
Not provided
Not provided
Not provided
|
|
| Superficial soft tissue massage | Other | 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 |
|
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Jeddah |
| Saudi Arabia |