Comparison of Neural Mobilization and Laser Therapy Impact on Pain and Disability in Patients with Lateral Elbow Tendinopathy: An Unblinded Randomized Controlled Trial

Last registered on August 06, 2016

Pre-Trial

Trial Information

General Information

Title
Neural mobilization versus low level laser therapy in treating patients with chronic Lateral elbow tendinopathy:RCT
RCT ID
AEARCTR-0001479
Initial registration date
August 06, 2016

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
August 06, 2016, 6:08 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
August 06, 2016, 6:13 AM EDT

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Region

Primary Investigator

Affiliation
cairo university

Other Primary Investigator(s)

Additional Trial Information

Status
Completed
Start date
2015-05-20
End date
2016-06-01
Secondary IDs
Abstract
Background: Lateral elbow tendinopathy is a frequently encountered upper extremity dysfunctions in clinical practice. prolonged symptoms or relapse upon return to the offending activity represent one of the health care challenges. Objective. to evaluate the effectiveness of neural mobilization versus low level laser therapy on chronic Lateral elbow tendinopathy. Design. The study was designed as a single blind randomized controlled trial. Setting: The study was conducted in the outpatient clinic of the faculty of Physical Therapy, Cairo University. Patients. Sixty patients with unilateral chronic Lateral elbow tendinopathy were randomly assigned to control group (n=20), neural mobilization group (n=20), and laser group (n=20).Intervention. control group received ultrasound therapy and deep friction massage. The neural mobilization intervention consisted of radial nerve mobilization for the affected arm 3sessions per week up to 6 weeks. Meanwhile laser group received (904 Ga-As laser, energy density 2.4 J/cm2). Outcome measures were the visual analog scale (VAS), the disability of arm, shoulder and hand questionnaire (DASH score), and hand grip strength .Measurements. Analyses of variance test was used to determine differences between groups for all measured parameters. Paired t-test was used to compare between the pre- and post-treatment values within groups.Results. For the 60 study participants (26 women and 34 men; mean age=39.3±6.2) years there were no between-group differences at baseline in VAS, Dash score, and grip strength . At the end of the 6-week of intervention, Subjects in mobilization and laser groups experienced significant decrease in pain and improve in function disability than those in the control group (p>0.05) . Pain and functional disability were significantly improved in mobilization group compared with the laser group, while there was no significant difference in grip strength between three groups (p>0.05).Limitations. Lack of a cost-benefit analysis and follow up analysis were limitations of the study. Discussion and Conclusion. The results suggest that neural mobilization could be effective treatment option for management of low level laser when pain and functional disability are the main patient complains.
External Link(s)

Registration Citation

Citation
Atya, Azza. 2016. "Neural mobilization versus low level laser therapy in treating patients with chronic Lateral elbow tendinopathy:RCT ." AEA RCT Registry. August 06. https://doi.org/10.1257/rct.1479-2.0
Former Citation
Atya, Azza. 2016. "Neural mobilization versus low level laser therapy in treating patients with chronic Lateral elbow tendinopathy:RCT ." AEA RCT Registry. August 06. https://www.socialscienceregistry.org/trials/1479/history/9966
Experimental Details

Interventions

Intervention(s)
Intervention Start Date
2015-10-01
Intervention End Date
2016-03-01

Primary Outcomes

Primary Outcomes (end points)
PAIN
Disability of arm, shoulder and hand questionnaire (DASH score)
Hand grip strength
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
This study is single blind randomized controlled trial design. Randomization was performed using computer-generated random number tables. Patients were randomly allocated to three equal groups. Group I (control group) (n=20) received conventional modalities including ultrasound therapy and friction massage. Group II (NM group) (n=20) received radial nerve mobilization using a series of 8 oscillations and repeated 3 times with a one minute rest in between. Group III (n=20) (laser group)was treated with low level laser (an energy dose of 0.275 J per tender point).all the patients were treated every other day for 6 weeks.
Experimental Design Details
Randomization Method
Randomization was performed using computer-generated random number tables
Randomization Unit
outpatient of faculty of physical therapy
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
65 patients
Sample size: planned number of observations
65 patients
Sample size (or number of clusters) by treatment arms
60 patients :20control,20neural mobilization,20 laser
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials