| CTRI Number |
CTRI/2019/08/020554 [Registered on: 05/08/2019] Trial Registered Prospectively |
| Last Modified On: |
02/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of physiotherapy exercises on neck pain in industrial workers |
|
Scientific Title of Study
|
Effectiveness of McKenzie exercises alongwith stretching and ergonomic advice on nonspecific neck pain in industrial workers- A single blind randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nilesh Dattatray Dond |
| Designation |
Post Graduate student |
| Affiliation |
Pad.Dr.Vithalrao vikhe patil, COPT |
| Address |
Pad.Dr.Vithalrao vikhe patil, COPT, Department of musculoskeletal
sciences Opp. Govt. Milk dairy,M.I.D.C., Ahmednagar-414111
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
8975319879 |
| Fax |
|
| Email |
nilesh.dond11@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Anap |
| Designation |
Professor & HOD, Musculoskeletal sciences |
| Affiliation |
Pad.Dr.Vithalrao vikhe patil, COPT |
| Address |
Pad.Dr.Vithalrao vikhe patil, COPT, Department of musculoskeletal
sciences, Opp. Govt. Milk dairy,M.I.D.C., Ahmednagar-414111
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9890200972 |
| Fax |
|
| Email |
deepak.anap@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Anap |
| Designation |
Professor & HOD, Musculoskeletal sciences |
| Affiliation |
Pad.Dr.Vithalrao vikhe patil, COPT |
| Address |
Pad.Dr.Vithalrao vikhe patil, COPT, Department of musculoskeletal
sciences, Opp. Govt. Milk dairy,M.I.D.C., Ahmednagar-414111
MAHARASHTRA
414111
India |
| Phone |
9890200972 |
| Fax |
|
| Email |
deepak.anap@hotmail.com |
|
|
Source of Monetary or Material Support
|
| DVVPFS college of physiotherapy Ahmednagar |
|
|
Primary Sponsor
|
| Name |
DVVPFS COLLEGE OF PHYSIOTHERAPY |
| Address |
opp.Govt.milk Dairy,M.I.D.C.Ahemednagar- 414111 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nilesh Dond |
Pad.Dr vithalrao vikhe patil foundations college of physiotherapy |
Department: Musculoskeletal physiotherapy OPD, Opp.Govt.Milk Dairy, MIDC, Ahmednagar- 414111 Ahmednagar MAHARASHTRA
Ahmadnagar
MAHARASHTRA |
9112079699
nilesh.dond11@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Postural syndrome/ Nonspecific neck pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
McKenzie exercises, stretching exercises and ergonomic advices |
McKenzie exercises:
all exercises will be repeated ten to fifteen times.
Management of extension dysfunction
1.Retraction
2.Retraction with patient overpressure
3.Retraction with extension
Management of rotation dysfunction
1.Rotation
2.Rotation with patient overpressure
Management of lateral flexion dysfunction
1.Lateral flexion
2.Lateral flexion with patient over pressure
Retraction with Shoulder Elevation
Stretching exercises:
The set of exercises will be designed to be performed once a day/3 times a week, with each session last approximately10---15 min. Each individual exercise includes 10 repetitions (or last for a period of 10---15 s) and 3 sets (with a rest of 60---90 s between sets) 4times a day on alternate days under the supervision of the Certified Specialist
1.Neck stretches retraction
2.Rotate Head From Side To Side
3.Tilt head From Front To Back
4.Tilt head From Side To Side
all exercises will be Hold posture for 10 – 15 seconds. Return your head to the centre Repeat 2 or 3 times.
Ergonomic Advice:
Prior to the ergonomic advice information about non specific neck pain and ergonomical importance will be provided to all participants who involved in study.
Task specific ergonomic advice will be given to the participants in both experimental group and control group.
|
| Comparator Agent |
Stretching exercises and Ergonomic Advice |
Stretching exercises: The set of exercises will be designed to be performed once a day/3 times a week, with each session last approximately10---15 min. Each individual exercise includes 10 repetitions (or last for a period of 10---15 s) and 3 sets (with a rest of 60---90 s between sets) 4times a day on alternate days under the supervision of the Certified Specialist 1.Neck stretches retraction 2.Rotate Head From Side To Side 3.Tilt head From Front To Back 4.Tilt head From Side To Side all exercises will be Hold posture for 10 – 15 seconds. Return your head to the centre Repeat 2 or 3 times. Ergonomic Advice: Prior to the ergonomic advice information about non specific neck pain and ergonomical importance will be provided to all participants who involved in study. Task specific ergonomic advice will be given to the participants in both experimental group and control group. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Willing to participate.
Age group of 20 years - 50 years.
At least 1 years of working experience.
Patients with postural syndrome only
8 hours duty with 1hr break( 8:00am- 5:00pm)
Participant has to report WMSDs in neck region of his/her body |
|
| ExclusionCriteria |
| Details |
Degenerative cervical pathology with radiculopathy
Cardiovascular diseases, medical history (e.g. heart failure, chest pain during physical exercise, stroke and myocardial infarction).
Severe or traumatic injury to the neck regions for the past year.
psychiatric, pathological or neurological disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Nordic musculoskeletal questionnaire
2.Neck disability index
3.Pressure biofeedback unit
|
At baseline,
At 1 Month,
At 2 Months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Title: Effectiveness of McKenzie exercises along with stretching and ergonomic advice on non specific neck pain in industrial workers – A single blinded randomized control trial.
Method: All patients will be explained about study procedure, intervention and benefit of current research. return and verbal informed consent will be taken from all the patients before including in study. Demographic information of patients including age gender occupation any history of systemic diseases medications will be documented. Routine assessment of the patients will be done including pain MMT with the help of pressure bio feedback unit assessment and presence of postural syndrome. Neck Disability index (NDI) will be filled by patients for evaluation of disability at base line, at one month and two months. The patients will be randomly divided in to two groups intervention and control group and they will be blinded to the treatment.
Interventions: The intervention group will receiving a session of Mckenzie exercises, stretching exercises and ergonomic advice for neck for 4 weeks under supervision and 4 weeks self exercises at home .The control group will be receiving stretching exercises and ergonomic advice for 4 weeks under supervision and 4 weeks self exercises at home. The results obtained will be statistically calculated. |