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Trial registered on ANZCTR


Registration number
ACTRN12613001307796
Ethics application status
Approved
Date submitted
19/11/2013
Date registered
25/11/2013
Date last updated
25/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Normal Cervical Sagittal Configuration in the Management of Cervicogenic Dizziness: A 1-Year Randomized Controlled Study
Scientific title
The effect of Denneroll cervical traction in addition to multimodal program on anterior head translation distance, cervical lordosis, severity of dizziness, disability, and severity of cervical pain in patients with Cervicogenic Dizziness
Secondary ID [1] 283617 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervicogenic Dizziness 290541 0
Condition category
Condition code
Musculoskeletal 290939 290939 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 290940 290940 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients in study group completed 3 x 1 hour sessions per week for 10 weeks, multimodal program in forms of physical pain relief methods, cervical spine mobilization, myofascial release, and therapeutic exercises.
Physical pain relief methods: The patients received hot packs (15 minutes) and TENS therapy (20 minutes) to control pain and eliminate the causal role of muscle spasms and/or tightness in changing the posture parameters. The frequency was set to 80 Hz and pulse width to 50 micro due to its analgesic effect.

Mobilization : We started with neck palpation to find the most dysfunctional joints .Next, we performed passive joint mobilizations to those joints according to Maitland et al's regimen. This regimen includes the use of low-velocity cervical joint mobilization techniques (pressures were applied through the thumbs in postero-anterior direction, postero-anterior pressure were performed centrally over spinous processes and unilateral postero-anterior pressures were performed over articular pillars). It is usually applied three times for 30 seconds to dysfunctional joints.

Myofascial release technique, suboccipital release: Was performed with the patient in supine position. The therapist contacted the base of the occiput with the pads of the fingers to apply antero-cephalad traction, as the tissues started to relax, the pressure continued in the direction of ease (cephalad direction). The pressure is continued for 1 or 2 min until a release of the suboccipital tissues is obtained.

Therapeutic exercise intervention: ( about 30 minutes) According to Jull et al's protocol, the exercise component of the program consisted of deep cervical flexor endurance training, scapular retraction exercises, postural education, and low-load cervical flexion and extension resistive exercise. Deep cervical flexor exercises focused on the tonic holding function of these muscles. Exercises were performed in supine position with the pressure sensor inflated to 20 mmHg and placed behind the neck. The patients instructed to achieve and maintain 30 mmHg for 10 sec for 10 repetitions. From prone lying position, the muscles of the scapula, particularly the serratus anterior and lower trapezius, were trained using inner range holding exercises of scapular adduction and retraction. The patients were instructed to complete three sets of 12 repetitions.
Also, the patients were trained to sit with a natural lumbar lordosis while gently retracting and adducting their scapulae and gently elongating their cervical spine to facilitate the longus colli. Subsequently, isometric exercises using a low level of rotatory resistance were used to train the co-contraction of the neck flexors and extensors.the exercises was performed in three sets of 12 repetitions.
Muscle lengthening exercises were conducted to address any muscle tightness assessed to be present. Three stretching exercises held for 30 seconds each.


This multimodal programme was to be repeated three times per week for 10 weeks. The multimodal program was performed to participants at physiotherapy clinic. Patients were instructed to perform neck retraction/extension, scapular retraction, and deep upper cervical flexor strengthening exercises at home, twice daily as home routine (a pamphlet illustrating the exercises and a record sheet were distributed to the participants. the records sheets were collected every week and analysed to calculate the exercise frequency and time).
The experimental group additionally received Deneroll cervical traction. The patient lies flat on their back on the ground with their legs extended and arms by their sides. The patient is encouraged to relax whilst lying on the Denneroll. The patient should place the Denneroll on the ground and position the neck roll depending on the area to be addressed.

The apex of the Denneroll orthotic is placed in the upper cervical region (C2-C4) region. This position allows extension bending of the upper cervical segments while cause slight anterior head translation.
The apex of the Denneroll orthotic is placed in the mid-cervical region (C4-C6) region. This position allows extension bending of the mid-upper cervical segments while creating a slight posterior head translation.
The apex of the Denneroll orthotic is placed in the upper thoracic lower-cervical region (C6-T1) region. This position allows extension bending of the majority of cervical segments while creating a significant posterior head translation.
The Denneroll cervical traction was administered by physiotherapist, and was performed to patients at physiotherapy clinic.
The time of the Denneroll cervical traction was 3 minutes at the first session and increased by 1 minutes in every session till it reached 20 minutes.
Intervention code [1] 288309 0
Treatment: Devices
Intervention code [2] 288310 0
Rehabilitation
Comparator / control treatment
The patients in control group completed a 10-week multimodal program in forms of physical pain relief methods, cervical spine mobilization, myofascial release, and therapeutic exercises.
Physical pain relief methods: The patients received hot packs (15 minutes) and TENS therapy to control pain and eliminate the causal role of muscle spasms and/or tightness in changing the posture parameters. The frequency was set to 80 Hz and pulse width to 50 micro due to its analgesic effect.

Mobilization : We started with neck palpation to find the most dysfunctional joints .Next, we performed passive joint mobilizations to those joints according to Maitland et al's regimen. This regimen includes the use of low-velocity cervical joint mobilization techniques (pressures were applied through the thumbs in postero-anterior direction, postero-anterior pressure were performed centrally over spinous processes and unilateral postero-anterior pressures were performed over articular pillars). It is usually applied three times for 30 seconds to dysfunctional joints.

Myofascial release technique, suboccipital release: Was performed with the patient in supine position. The therapist contacted the base of the occiput with the pads of the fingers to apply antero-cephalad traction, as the tissues started to relax, the pressure continued in the direction of ease (cephalad direction). The pressure is continued for 1 or 2 min until a release of the suboccipital tissues is obtained.

Therapeutic exercise intervention: According to Jull et al's protocol, the exercise component of the program consisted of deep cervical flexor endurance training, scapular retraction exercises, postural education, and low-load cervical flexion and extension resistive exercise. Deep cervical flexor exercises focused on the tonic holding function of these muscles. Exercises were performed in supine position with the pressure sensor inflated to 20 mmHg and placed behind the neck. The patients instructed to achieve and maintain 30 mmHg for 10 sec for 10 repetitions. From prone lying position, the muscles of the scapula, particularly the serratus anterior and lower trapezius, were trained using inner range holding exercises of scapular adduction and retraction. Also, the patients were trained to sit with a natural lumbar lordosis while gently retracting and adducting their scapulae and gently elongating their cervical spine to facilitate the longus colli. 18 Subsequently, isometric exercises using a low level of rotatory resistance were used to train the co-contraction of the neck flexors and extensors. Muscle lengthening exercises were conducted to address any muscle tightness assessed to be present.

This multimodal programme was to be repeated three times per week for 10 weeks. Patients were instructed to perform neck retraction/extension, scapular retraction, and deep upper cervical flexor strengthening exercises at home, twice daily as home routine.
the patients in the control group received only the multimodal programme. they did not received Denneroll cervical traction
Control group
Active

Outcomes
Primary outcome [1] 290922 0
The primary outcome measure for determining the treatment assessment was disability measured by using the Dizziness Handicap Inventory. A 25-item self-assessment inventory designed to evaluate the self-percieved handicapping effects imposed by dizziness with a maximum score of 100 points indicating severe disability and with 18 points indicating a clinically important change
Timepoint [1] 290922 0
pretreatment, 10 weeks post-treatment, and at one year of follow-up
Secondary outcome [1] 305601 0

Severity of dizziness (an average level over the previous few days) measured with a 10 cm visual analogue scale. The visual analogue scale has been used to measure dizziness in other studies.
Timepoint [1] 305601 0
pretreatment, 10 weeks post-treatment, and at one year of follow-up
Secondary outcome [2] 305639 0
A repeatable and reliable Jackson et al’s method was used to quantify cervical lordosis angle and anterior head translation distance. Standard lateral cervical radiographs were obtained at three intervals. The posterior-superior and posterior-inferior vertebral body corners on the lateral cervical radiographs were marked and two tangents lines were extended down from the posterior margin of the second cervical vertebral body and up from the posterior margin of the seventh cervical vertebral body. The absolute rotatory angle which is formed by the intersection of the tangents drawn at the posterior body margins of C2 and C7 was measured by the protractor. For measuring the anterior head translation distance, a superior vertical line was constructed from the postero-inferior corner of C7 and the perpendicular distance from this line to the postero-superior portion of the vertebral body of C2 was measured by a ruler.
Timepoint [2] 305639 0
pretreatment, 10 weeks post-treatment, and at one year of follow-up
Secondary outcome [3] 305640 0
Severity of cervical pain was measured using separate 0-10 numerical rating scale. The patients were asked to place a mark along the line to denote their pain level; 0 reflecting ‘‘no pain’’ and 10 reflecting the ‘‘worst pain ’’.

Timepoint [3] 305640 0
pretreatment, 10 weeks post-treatment, and at one year of follow-up

Eligibility
Key inclusion criteria
All potential participants with suspected cervicogenic dizziness were invited to undergo comprehensive assessment by a neurologist in which other causes of dizziness were excluded. They were screened prior to inclusion by measuring their lateral cervical radiographs for a cervical absolute rotatory angle from the posterior body margins of C2-C7 and anterior head translation. If the absolute rotatory angle was less than 25 degrees and anterior head translation distance was more than 15 mm then a participant was included in the study.

Further, the patients were included if they had a recurrent episodes of dizziness (by self-report) with symptoms lasting longer than three months, dizziness that can be provoked by certain head positions or movements, dizziness described as imbalance or unsteadiness (not rotatory vertigo),and dizziness associated with stiff or painful neck.
Minimum age
40 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included previous history of stroke, a diagnosis of a bleeding disorder, currently undergoing anticoagulation treatment, presence of inflammatory joint disease, infection, tumor, or fracture of the spine or cranium, central vascular/ neurologic condition suspected of causing neck pain and/or dizziness/vertigo and evidence of narcotic or other drug abuse.

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)
The patients were randomly assigned to the treatment group or the control group by an independent person who selected numbers from sealed envelopes containing numbers chosen by a random number generator. The randomization was restricted to permuted blocks of different sizes to ensure that equal numbers were allocated to each group. Each random permuted block was transferred to a sequence of consecutively numbered, sealed, opaque envelopes that 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)
Randomization was restricted to permuted blocks of different sizes to ensure equal numbers being allocated to each group
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 determine the required number of samples in this study, estimates of mean and standard deviation were collected from a pilot study consisting of 10 patients who received the same programme between January 1, 2010, and December 30, 2010. The mean differences and standard deviation of Dizziness Handicap Inventory score were estimated as 11 and 15, respectively. According to these figures, at least 30 subjects given a significance level of 5% and statistical power of 80%. To account for the possible drop-out rates, the sample size was increased by 20%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5642 0
Egypt
State/province [1] 5642 0

Funding & Sponsors
Funding source category [1] 288297 0
Self funded/Unfunded
Name [1] 288297 0
Address [1] 288297 0
Country [1] 288297 0
Primary sponsor type
Individual
Name
Ibrahim Moustafa Moustafa
Address
Faculty of Physical Therapy, cairo university, Egypt 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. Postal Code: 12612
Country
Egypt
Secondary sponsor category [1] 287017 0
Individual
Name [1] 287017 0
Aliaa Attiah Diab


Address [1] 287017 0
Faculty of Physical Therapy, cairo university, Egypt

7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt.

Postal Code: 12612
Country [1] 287017 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290193 0
Ethics Committee of the Faculty of Physical Therapy, Cairo Univercity
Ethics committee address [1] 290193 0
Faculty of Physical Therapy - Cairo University 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. Postal Code: 12612
Ethics committee country [1] 290193 0
Egypt
Date submitted for ethics approval [1] 290193 0
Approval date [1] 290193 0
27/10/2010
Ethics approval number [1] 290193 0

Summary
Brief summary
The purpose of this study was To investigate the immediate and long-term effects of a 1-year multimodal program, with the addition of cervical sagittal curve restoration and forward head correction, on severity of dizziness, disability, and severity of cervical pain. In this study, 72 (35 female) patients between 40 and 55 years with cervicogenic dizziness, definite hypolordotic cervical spine and forward head posture were randomly assigned to the control or experimental group. Both groups received the multimodal program, additionally, the study group received the Denneroll cervical traction. Outcome measures included anterior head translation distance, cervical lordosis, severity of dizziness, disability, and severity of cervical pain. in this study ,we hypothesized that the addition of Dennroll cervical traction to a multimodal program can positively affect dizziness management outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44422 0
A/Prof Ibrahim Moustafa Moustafa
Address 44422 0
faculty of physical therapy- Cairo university 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. Postal Code: 12612
Country 44422 0
Egypt
Phone 44422 0
+201227022334
Fax 44422 0
Email 44422 0
ibrahiem.mostafa@pt.cu.edu.eg
Contact person for public queries
Name 44423 0
A/Prof Ibrahim Moustafa Moustafa
Address 44423 0
faculty of physical therapy- Cairo university 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. Postal Code: 12612
Country 44423 0
Egypt
Phone 44423 0
+201227022334
Fax 44423 0
Email 44423 0
ibrahiem.mostafa@pt.cu.edu.eg
Contact person for scientific queries
Name 44424 0
A/Prof Ibrahim Moustafa Moustafa
Address 44424 0
faculty of physical therapy- Cairo university 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. Postal Code: 12612
Country 44424 0
Egypt
Phone 44424 0
+201227022334
Fax 44424 0
Email 44424 0
ibrahiem.mostafa@pt.cu.edu.eg

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary