Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201910748422700 Date of Approval: 24/10/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The addition of a sagittal thoracic posture corrective orthotic device to a multimodal rehabilitation program improves short and long term outcomes in patients with Chronic nonspecific neck pain: A randomized-controlled trial.
Official scientific title The addition of a sagittal thoracic posture corrective orthotic device to a multimodal rehabilitation program improves short and long term outcomes in patients with Chronic nonspecific neck pain: A randomized-controlled trial.
Brief summary describing the background and objectives of the trial : Many authors have suggested that because of biomechanical, anatomical and nerve relationships between the cervical and thoracic spine, disturbances in the thoracic region could contribute to the maintenance of neck pain. For these reasons, it seems possible that therapeutic interventions directed at the thoracic spine may have therapeutic effects on the cervical spine. However, there is a lack of controlled studies evaluating the effect of thoracic hyperkyphosis rehabilitation in chronic nonspecific neck pain. The purpose of this study was to investigate the immediate and 1-year effects of a multimodal program, with thoracic hyperkyphosis rehabilitation using the Denneroll Thoracic Traction Orthosis (DTTO), on the pain, disability, sensorimotor function; head and eye movement control (smooth pursuit ) and postural stability for subjects with chronic nons-pecific neck pain and thoracic hyperkyphosis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/09/2018
Actual trial start date 01/09/2018
Anticipated date of last follow up 31/08/2019
Actual Last follow-up date 06/10/2019
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 80
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group combined Sagittal thoracic orthosis with the multimodal rehabilitation 3 times per week 10 weeks Physical pain relief methods TENS The patients in both groups received conventional TENS therapy (20 minutes) TENS was applied over the painful area ,using frequency of 80 Hz; pulse width of 50 µs; intensity (mA) exclusively set at the subject's sensorial threshold; modulation up to 50% of variation frequency; symmetrical rectangular biphasic waveform and length of application of 20 minutes. These parameters were set due to its analgesic effect.23 Hot packs (15 minutes) were applied prior to electrical stimulation to improve the effectiveness of the treatment. Soft Tissue Mobilization Soft tissue mobilization was performed on the muscles of the upper quarter with the involved upper extremity positioned in abduction and external rotation to preload the neural structures of the upper limb.26 Manual pressure was applied to the soft tissues of the upper quadrant in a deep, stroking manner. Strengthening Exercises The strengthening exercise program deep cervical flexors, shoulder retractors, and serratus anterior was conducted according to the protocol described in Harman et al All the multimodal program components were repeated three times per week for 10 weeks,. All participants completed the multimodal program at our physiotherapy clinic. Denneroll extension traction The participants in the experimental group also received the a sagittal thoracic posture corrective orthotic. The denneroll orthotic was only performed in the physiotherapy clinic setting. The patients were instructed to lie flat on their back on the ground with their legs extended and arms by their sides gently folded across their stomach. The patient placed the denneroll on the ground and the examiner positioned the apex of the denneroll in one of three regions( Lower thoracic, Mid-Thoracic, and Upper-Thoracic) depending on the apex of each participant’s thoracic curvature deformity. Home exercise: neck retraction/extension, scapular retraction, and deep upper cervical flexor strengthening 37
Control Group multimodal rehabilitation program 3 times per week 10 weeks Physical pain relief methods TENS The patients in both groups received conventional TENS therapy (20 minutes) TENS was applied over the painful area ,using frequency of 80 Hz; pulse width of 50 µs; intensity (mA) exclusively set at the subject's sensorial threshold; modulation up to 50% of variation frequency; symmetrical rectangular biphasic waveform and length of application of 20 minutes. These parameters were set due to its analgesic effect. Hot packs (15 minutes) were applied prior to electrical stimulation to improve the effectiveness of the treatment. Soft Tissue Mobilization Soft tissue mobilization was performed on the muscles of the upper quarter with the involved upper extremity positioned in abduction and external rotation to preload the neural structures of the upper limb. Manual pressure was applied to the soft tissues of the upper quadrant in a deep, stroking manner. Strengthening Exercises The strengthening exercise program deep cervical flexors, shoulder retractors, and serratus anterior was conducted according to the protocol described in Harman et al 43 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
kyphotic angle ICT-ITL (max) using a 4D formetric device more than 55 degrees presence of any signs or symptoms of medical "red flags" (e.g., tumor, fracture, rheumatoid arthritis, osteoporosis, and prolonged steroid use), a history of previous cervical or thoracic spine surgery, signs or symptoms of upper motor neuron disease, vestibulobasilar insufficiency, amyotrophic lateral sclerosis, and bilateral upper extremity radicular symptoms. Adult: 19 Year-44 Year 30 Year(s) 40 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/06/2018 Faculty of physical Therapy Ethical review committee
Ethics Committee Address
Street address City Postal code Country
Ahmad Al Zayat Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome kyphotic angle ICT-ITL (max) Measures were assessed at three time intervals: baseline, 10 weeks, and 1 year after the 10 week follow up.
Secondary Outcome Neck disability index - The neck disability index (NDI) was used to measure disability. NDI consists of 10 items related to daily living activities. Measures were assessed at three time intervals: baseline, 10 weeks, and 1 year after the 10 week follow up.
Secondary Outcome Sensorimotor control. Assessment of sensorimotor function included cervical joint position sense testing , Head and eye movement control , and evaluation of postural stability. Measures were assessed at three time intervals: baseline, 10 weeks, and 1 year after the 10 week follow up.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic Faculty of Physical therapy Cairo university Ahmad Al Zayat Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Chiropractic Biophysics 950. E. Riverside Drive Eagle Idaho 83616 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy cairo University Ahmad Al Zayat Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ibrahim Moustafa Moustafa Ahmad Al Zayat street Giza Egypt
Tamer Mohamed Shousha Ahmed Al Zayat Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Ibrahim Moustafa ibrahiem.moustafa@pt.cu.edu.eg +201227022334 Ahmad Al Zayat
City Postal code Country Position/Affiliation
Giza Egypt Assistant Professor
Role Name Email Phone Street address
Principal Investigator Ibrahim Moustafa ibrahiem.mostafa@pt.cu.edu.eg +201227022334 Ahmad Al Zayat
City Postal code Country Position/Affiliation
Giza Egypt Assistant Professor
Role Name Email Phone Street address
Public Enquiries Tamer Shousha shoushadoc@cu.edu.eg +01227900667 Ahmad Al Zayat
City Postal code Country Position/Affiliation
Giza Egypt Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary of results will be provided on demand Study Protocol within 12 month open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information