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Trial registered on ANZCTR


Registration number
ACTRN12613000321741
Ethics application status
Approved
Date submitted
16/03/2013
Date registered
22/03/2013
Date last updated
22/03/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of forward head posture corrective exercises in the management of lumbosacral radiculopathy: A 2-year randomized controlled study
Scientific title
the effects of forward head posture corrective exercises in addition to functional restoration program on disability in patients with chronic discogenic lumbosacral radiculopathy.
Secondary ID [1] 282135 0
Nil
Universal Trial Number (UTN)
U1111-1140-6913
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic discogenic lumbosacral radiculopathy. 288631 0
Condition category
Condition code
Physical Medicine / Rehabilitation 288967 288967 0 0
Physiotherapy
Musculoskeletal 289010 289010 0 0
Other muscular and skeletal disorders
Neurological 289011 289011 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients in both groups completed a 10-week functional restoration programme supervised by a physical therapist. Exercises then were continued more independently for a 2-year period at a public gymnasium. The exercise component of the patient’s programme consisted of 3 main phases. In phase 1, the patient attended 2 sessions per week for 4 weeks, during this phase the patient first was educated regarding his injury. The patient was taught self-management strategies aimed at minimizing therapist dependence and empowering the patient to gain control over symptoms. In addition to implementing educational, self-management strategies, retraining of the transversus abdominis, lumbar multifidus, and pelvic-floor muscles started during this phase. The next stage of rehabilitation consisted of integrating the stabilizing pattern into a clinic-based, supervised functional restoration programme. In this stage, the patient attended the clinic 3 times per week for a 6-week period, and completed 2 additional exercise sessions each week at home. In the phase1 and 2, the sessions are administered on group basis. A maximum of five patients were included in the group, the number being limited by space . Each session lasted for 90 minutes.
Following phase 2 of the functional restoration programme, the patient then commenced phase 3 of management, consisting of a relatively independent exercise programme at a public gymnasium in the form of endurance and low impact aerobic exercise. At this phase, all the patients are trained with a twice-per-week frequency .The sessions are administered on individual basis, each session lasted for 20 to30 minutes. Throughout all phases of the exercise programme, cognitive-behavioral strategies were used by the physical therapist, cognitive strategies included challenging counterproductive beliefs such as unrealistic expectations regarding recovery time frames and emphasizing the relative benefits of active exercise and self-management as opposed to passive treatment. Behavior modification included positive reinforcement of wellness behaviors such as increasing exercise intensity. Certain social behaviors such as returning to social activity and performing domestic tasks also were positively reinforced. A detailed functional restoration programme has been published previously .
Those in the control group received this functional restoration programme only. The experimental group additionally received a posture corrective exercise programme in the form of two strengthening (deep cervical flexors and shoulder retractors) and two stretching (cervical extensors and pectoral muscles) exercises. The exercise programme was done according to Harman et al.’s protocol and based on Kendall et al.’s approach. The forward head posture corrective exercise programme commences concurrently with the start of Phase one of functional restoration programme , lasted for 30 minutes, and is strictly on a one-on-one basis only. A detailed posture corrective exercise programme has been published previously. This exercise programme was to be repeated four times per week for 10 weeks.

Intervention code [1] 286741 0
Rehabilitation
Comparator / control treatment
The patients in both groups completed a 10-week functional restoration programme supervised by a physical therapist. Exercises then were continued more independently for a 2-year period at a public gymnasium. The exercise component of the patient’s programme consisted of 3 main phases. In phase 1, the patient attended 2 sessions per week for 4 weeks, during this phase the patient first was educated regarding his injury. The patient was taught self-management strategies aimed at minimizing therapist dependence and empowering the patient to gain control over symptoms. In addition to implementing educational, self-management strategies, retraining of the transversus abdominis, lumbar multifidus, and pelvic-floor muscles started during this phase. The next stage of rehabilitation consisted of integrating the stabilizing pattern into a clinic-based, supervised functional restoration programme. In this stage, the patient attended the clinic 3 times per week for a 6-week period, and completed 2 additional exercise sessions each week at home. In the phase1 and 2, the sessions are administered on group basis. A maximum of five patients were included in the group, the number being limited by space . Each session lasted for 90 minutes.
Following phase 2 of the functional restoration programme, the patient then commenced phase 3 of management, consisting of a relatively independent exercise programme at a public gymnasium in the form of endurance and low impact aerobic exercise. At this phase, all the patients are trained with a twice-per-week frequency .The sessions are administered on individual basis, each session lasted for 20 to30 minutes. Throughout all phases of the exercise programme, cognitive-behavioral strategies were used by the physical therapist, cognitive strategies included challenging counterproductive beliefs such as unrealistic expectations regarding recovery time frames and emphasizing the relative benefits of active exercise and self-management as opposed to passive treatment. Behavior modification included positive reinforcement of wellness behaviors such as increasing exercise intensity. Certain social behaviors such as returning to social activity and performing domestic tasks also were positively reinforced. A detailed functional restoration programme has been published previously .
Those in the control group received this functional restoration programme only.
Control group
Active

Outcomes
Primary outcome [1] 289095 0
disability:Disability was measured using the Oswestry Disability Index
Timepoint [1] 289095 0
pre-treatment, 10 weeks post-treatment, and at 2- year follow-up
Secondary outcome [1] 301761 0
anterior head translation distance :Standard lateral cervical radiographs was used to quantify this distance
Timepoint [1] 301761 0
pre-treatment, 10 weeks post-treatment, and at 2- year follow-up
Secondary outcome [2] 301876 0
three dimensional spinal posture parameters:Rasterstereography (Formetric 2, Diers International GmbH, Schlangenbad, Germany) was used to examine this variable
Timepoint [2] 301876 0
pre-treatment, 10 weeks post-treatment, and at 2- year follow-up
Secondary outcome [3] 301877 0
pain intensity :Separate 0-10 numerical rating scale was used to measure the average intensity of back pain and leg pain
Timepoint [3] 301877 0
pre-treatment, 10 weeks post-treatment, and at 2- year follow-up
Secondary outcome [4] 301878 0
neurophysiological findings represented in latency and amplitude of H reflex:An electromyogram device (Tonneisneuroscreen plus version 1.59, Germany) was used to measure this variable
Timepoint [4] 301878 0
pre-treatment, 10 weeks post-treatment, and at 2- year follow-up

Eligibility
Key inclusion criteria
the patients were included if they had a confirmed chronic unilateral lumbosacral radiculopathy associated with L5-S1 lumbar disc prolapse with symptoms lasting longer than 3 months to avoid the acute stage of inflammation.Further, All patients had side-to-side H reflex latency differences of more than 1msec. Patients were also selected with lumbar hyperlordosis, which is considered a common posture aberrations in chronic low back pain patients
Minimum age
44 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included previous history of lumbosacral surgery, metabolic system disorder, cancer, cardiac problems, peripheral neuropathy, history of upper motor neuron lesion, spinal canal stenosis, rheumatoid arthritis, osteoporosis and any lower extremity deformity that might interfere with global postural alignment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients were randomly assigned by an independent person who picked one of the sealed envelopes, which contained numbers chosen by random number generator. Randomization was restricted to permuted blocks of different sizes to ensure equal numbers being allocated to each group. Each random permuted block was transferred to a sequence of consecutively numbered, sealed, opaque envelopes and these were stored in a locked drawer until required. As each participant formally entered the trial, the researcher opened the next envelope in the sequence in the presence of the patient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients were randomly assigned by an independent person who picked one of the sealed envelopes, which contained numbers chosen by random number generator. Randomization was restricted to permuted blocks of different sizes to ensure equal numbers being allocated to each group. Each random permuted block was transferred to a sequence of consecutively numbered, sealed, opaque envelopes and these were stored in a locked drawer until required. As each participant formally entered the trial, the researcher opened the next envelope in the sequence in the presence of the patient.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
To compare the experimental group and the control group, statistical analysis was based on the intention-to-treat principle and p-values less than .05 were considered significant. We used multiple imputations to handle missing data. To impute the missing data we constructed multiple regression models including variables potentially related to the fact that the data were missing and also variables correlated with that outcome. The equality of variances (Levene’s test) and the normal distribution of the data (KolmogoroveSmirnov’s test) lending to parametric methods for significance testing. In order to examine comparative treatment effects of the two alternative treatments over the course of the 2-year follow-up, an intent-to-treat repeated measures analyses (using the SPSS general linear model) was conducted for the 154 patients who entered the study. The models included one independent factor (group), one repeated measure (time) and an interaction factor (group × time). (The baseline value of the outcome as covariates was used to assess between group differences: baseline outcome in the mode= baseline value – overall mean baseline value). Independent sample test was used to determine the efficacy of forward head correction group and that of traditional treatment at different follow-up time points.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/01/2010
Actual
10/01/2010
Date of last participant enrolment
Anticipated
3/10/2010
Actual
31/10/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
154
Accrual to date
Final
Recruitment outside Australia
Country [1] 4941 0
Egypt
State/province [1] 4941 0
Giza

Funding & Sponsors
Funding source category [1] 286904 0
Self funded/Unfunded
Name [1] 286904 0
Country [1] 286904 0
Primary sponsor type
Individual
Name
Ibrahim Moustafa Moustafa
Address
7 Mohamed Hassan El gamal Street, Abbas El Akkad, Nasr City, Egypt.
postal code:11471
Country
Egypt
Secondary sponsor category [1] 285691 0
None
Name [1] 285691 0
Address [1] 285691 0
Country [1] 285691 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288963 0
faculty counsel for post graduated study and researcher
Ethics committee address [1] 288963 0
Ethics committee country [1] 288963 0
Egypt
Date submitted for ethics approval [1] 288963 0
Approval date [1] 288963 0
Ethics approval number [1] 288963 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38538 0
Dr Ibrahim Moustafa Moustafa
Address 38538 0
7 Mohamed Hassan El gamal Street, Abbas El Akkad, Nasr City, Egypt
the Principal Investigator's organisation :Faculty of Physical Therapy- cairo university
postal code:11471
Country 38538 0
Egypt
Phone 38538 0
+20127022334
Fax 38538 0
Email 38538 0
ibrahiem.mostafa@pt.cu.edu.eg
Contact person for public queries
Name 38539 0
Ibrahim Moustafa Moustafa
Address 38539 0
7 Mohamed Hassan El gamal Street, Abbas El Akkad, Nasr City, Egypt.
the contact person's organisation:Faculty of Physical Therapy- cairo university
postal code:11471
Country 38539 0
Egypt
Phone 38539 0
+20127022334
Fax 38539 0
Email 38539 0
ibrahiem.mostafa@pt.cu.edu.eg
Contact person for scientific queries
Name 38540 0
Ibrahim Moustafa Moustafa
Address 38540 0
7 Mohamed Hassan El gamal Street, Abbas El Akkad, Nasr City, Egypt
the contact person's organisation:Faculty of Physical Therapy- cairo university
postal code:11471
Country 38540 0
Egypt
Phone 38540 0
+20127022334
Fax 38540 0
Email 38540 0
ibrahiem.mostafa@pt.cu.edu.eg

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of adding forward head posture corrective exercises in the management of lumbosacral radiculopathy: A randomized controlled study.2015https://dx.doi.org/10.1016/j.jmpt.2014.11.009
N.B. These documents automatically identified may not have been verified by the study sponsor.