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Strengthening exercises for the cervical extensors can help restore physiological lordosis and reduce neck pain
Last registered on January 27, 2016

Pre-Trial

Trial Information
General Information
Title
Strengthening exercises for the cervical extensors can help restore physiological lordosis and reduce neck pain
RCT ID
AEARCTR-0001013
Initial registration date
January 27, 2016
Last updated
January 27, 2016 7:44 AM EST
Location(s)
Region
Primary Investigator
Affiliation
Other Primary Investigator(s)
Additional Trial Information
Status
Completed
Start date
2014-03-18
End date
2015-08-07
Secondary IDs
Abstract
Aim: The aim of this study was to determine whether cervical extension strengthening will improve physiological curvature of the cervical spine and neck pain severity.
Methods: This was a three-month, prospective, observer-blinded, randomized controlled study with two mea¬surement points (baseline and three month). Patients were randomly assigned to two treatment groups. All patients were given etodolac (600 mg/day for 10 days). The control group received no additional treatment, while the intervention group received additional therapy as a home exercise program consisted of isometric neck extension strengthening forthree months. In both groups, the neck pain severity during rest was measured on a visual analogue scale (VAS).
Radiographs of the cervical spine were obtained at the time of admission and then at three months interval. The posterior tangent technique was used in evaluation of cervical lordosis. In accordance with this technique, the angle between the posterior walls of the vertebral bodies C2 and C7, which is called the total curvature of the cervical spine, was measured. As defined in the litearure, we considered loss of cervical lordosis or straight for the total curvature as +4º to -4º,and lordotic and kyphotic as <-4 and >+4, respectively.
Results: There were no significant differences in participants’ age, gender, height, weight or pain duration between two groups (p>0.05). At baseline, there was no difference in cervical lordosis angle or neck pain intensity between groups (p>0.05).
Compared with baseline at 3-month follow-up, cervical lordosis angle was significantly improved in the exercise group (P=0.000) but not in the control (P=0.371). Also, the exercisegroup was significantly superior than the control group considering the change data from baseline to month 3 in cervical lordosis angle (p=0.000). Similarly, considering the number of patients in whom cervical lordosis angle returned to normal, the exercise group was significantly superior than the control group (p=0.000).
At 3-month follow-up, the pain intensity was significantly reduced in both groups compared with baseline (all P=0.000). Nevertheless, consid¬ering the change data from baseline to month 3, there was significant difference between two groups in the pain intensity (P=0.000).
Conclusion: Strengthening exercises for the cervical extensors can help restore physiological lordosis and reduce neck pain.
External Link(s)
Registration Citation
Citation
ALPAYCI, MAHMUT. 2016. "Strengthening exercises for the cervical extensors can help restore physiological lordosis and reduce neck pain." AEA RCT Registry. January 27. https://doi.org/10.1257/rct.1013-1.0.
Former Citation
ALPAYCI, MAHMUT. 2016. "Strengthening exercises for the cervical extensors can help restore physiological lordosis and reduce neck pain." AEA RCT Registry. January 27. https://www.socialscienceregistry.org/trials/1013/history/6633.
Experimental Details
Interventions
Intervention(s)
Intervention Start Date
2014-04-22
Intervention End Date
2015-08-05
Primary Outcomes
Primary Outcomes (end points)
In both groups, the neck pain severity during rest was measured on a visual analogue scale (VAS).
Radiographs of the cervical spine were obtained at the time of admission and then at three months interval. The posterior tangent technique was used in evaluation of cervical lordosis. In accordance with this technique, the angle between the posterior walls of the vertebral bodies C2 and C7, which is called the total curvature of the cervical spine, was measured. As defined in the litearure, we considered loss of cervical lordosis or straight for the total curvature as +4º to -4º,and lordotic and kyphotic as <-4 and >+4, respectively.
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
This was a three-month, prospective, observer-blinded, randomized controlled study with two mea-surement points (baseline and three month). Patients were randomly assigned to two treatment groups. All patients were given etodolac (600 mg/day for 10 days). The control group received no additional treatment, while the intervention group received additional therapy as a home exercise program consisted of isometric neck extension strengthening forthree months.
Experimental Design Details
Randomization Method
draw
Randomization Unit
individual
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
>30 control and >30 treatment groups
Sample size: planned number of observations
85 cervical spine
Sample size (or number of clusters) by treatment arms
31 control and 34 treatment groups
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Yuzuncu Yil University
IRB Approval Date
2014-04-18
IRB Approval Number
18.04.2014/07
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers