| CTRI Number |
CTRI/2019/09/021028 [Registered on: 02/09/2019] Trial Registered Prospectively |
| Last Modified On: |
10/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of physiotherapy intervention (exercises) on sleep,pain and neck muscles in chronic neck pain subjects |
|
Scientific Title of Study
|
Studies on understanding the relationship between chronic neck pain and sleep disturbance: A physiotherapy intervention. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRZubia Veqar |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Jamia Millia Islamia-Centre for physiotherapy and rehabilitation Science
Jamia Nagar
North East
DELHI
110025
India |
| Phone |
9958993486 |
| Fax |
|
| Email |
veqar.zubia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRZubia Veqar |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Jamia Millia Islamia-Centre for physiotherapy and rehabilitation Science
Jamia Nagar
North East
DELHI
110025
India |
| Phone |
9958993486 |
| Fax |
|
| Email |
veqar.zubia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mosab Aldabbas |
| Designation |
Phd Scholar |
| Affiliation |
PhD scholar |
| Address |
centre for physiotherapy and rehabilitation sciences, jamia millia islamia
North East
DELHI
110025
India |
| Phone |
8447416274 |
| Fax |
|
| Email |
mosab.m.aldabbas@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Jamia Millia Islamia, Near to Jamia millia islamia metro station, Jamia Nagar, Okhla, New Delhi, Delhi 110025. |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Dr Zubia Veqar |
Centre for physiotherapy and Rehabilitation Science - Jamia Millia Islamia |
Sleep laboratory, Centre for physiotherapy and rehabiliation sciences, jamia millia islamia
South
DELHI |
9958993486
veqar.zubia@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| INDEPENDENT INSTITUTIONAL ETHICAL COMMITEE, JAMIA MILLIA ISLAMIA |
Approved |
| Jamia Millia Islamia |
Approved |
| Jamia Millia Islamia |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Neck Pain participants Who are free from and medical health problem |
| Patients |
(1) ICD-10 Condition: M998||Other biomechanical lesions, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group (15 participants) |
15 Healthy participants with normal sleep quality were included for comparison. Only pre data were collected for this group. |
| Intervention |
Myofascial Release
Strength and Endurance training |
The first experimental group (group 1) received progressive resistance-endurance exercises for the neck and shoulder muscles at a frequency of 5 sessions/week for first 2 weeks and 4 sessions/week for the following 5 weeks (7 weeks in total). The physiotherapy intervention focused on the neck muscle strength and endurance. Patients began the session with 10-15 minutes of warm up on the treadmill (8 km/h) followed by 5 minutes of general body stretching. Once warm up was completed, main phase of the treatment started with a hot pack for 15 minutes followed by gentle neck isometric exercises to facilitate activation of deep cervical muscles. The patients performed various exercises including chin tuck in, cranio-cervical flexion and cervical flexion from supine position, cervical and upper back extension from prone position. Shoulder exercises were performed while standing (shoulder shrugging and abduction). In the first few sessions, the exercises were performed without adding external resistance to avoid excessive loading of the cervical spine. Exercises for the neck and shoulders muscles were performed using TheraBand and dumbbells were used for shoulder muscles. Exercise intensity and repetitions were increased gradually based on individual patient feedback and tolerance. Neck endurance-resistance training was performed in sitting, supine and prone position. The duration of the session was gradually increased from 40-45 minutes to 70-80 minutes. Throughout the exercises, patients were instructed to move the head and neck slowly throughout the total range of motion to avoid any discomfort or symptom reproduction during the exercises.
The IFT was applied by an combined therapy device including (electrotherapy and ultrasound) (brand: Zimmer, D-89231 Neu-UIm, Germany). The following parameters of IFT were used: bipolar method of application with 4000Hz carrier frequency, with 90Hz a modulation frequency and amplitude modulated frequency of 60Hz. The electrodes were placed in opposition to the cervical spine (C5-C6-C7) for fifteen minutes. According to the sensitivity of each patient, the intensity of the IFT was adapted. The current intensity was increased gradually during the course of treatment without exceeding the pain threshold.
The second experimental group received the same exercises as the first group, IFT on the same parameters along with MFR. MFR was targeted on neck muscles including (upper trapezius muscle and suboccipital muscles). |
| Intervention |
Myofascial release
Strength- endurance training |
Strength- endurance training |
| Comparator Agent |
Myofascial release and Exercise |
Myofascial release and Exercise |
|
Inclusion Criteria
Modification(s)
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1 CNP patients who were poor sleepers (score > 5 on Pittsburgh Sleep Quality Index (PSQI).
2 Aged between 21 to 50 years.
3 Suffering from non-radicular CNP for at least 12 weeks < seven years (as it is documented that patients with long term chronic pain (> 7 years) have the capability of developing pain coping skills
4 Had a working knowledge of English |
|
| ExclusionCriteria |
| Details |
Patients were excluded if they were:
1 taking any prescribed medication that could impact sleep.
2 suffered from any other musculoskeletal pain condition or having any life-threatening condition
3 Reported any symptoms of Obstructive Sleep Apnea/Sleep disordered breathing.
4 Severe fatigue as assessed by Multidimensional Fatigue Inventory
5 Severe daytime sleepiness as assessed by the Epworth Sleepiness Scale( >15)
6 Frequent and severe headache and dizziness.
7 Severe depression and anxiety as assessed by Hospital Anxiety and Depression Scale (>10).
8 periodic Limb Movement Disorder rating of >5 .
9 Reported symptoms of Vertebrobasilar Insufficiency during physical examination.
10 High alcohol or caffeine alcohol intake.11
shift worker.
12 Having travelled across more than two time zones in the last month or having journeyed across more than one time zone in the last week. |
|
Method of Generating Random Sequence
Modification(s)
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1 Objective (PSG) sleep parameters.
2 Myoelectric Manifestations/fatigue parameters of upper trapezius (Mean, median power frequency and RMS).
3. Nocturnal Activity of upper trapezius during Wake, NREM and REM sleep.
4. Pain Intensity |
Pre intervention (day 0) and post intervention (after 7 weeks (30 sessions) |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
disability
Craniocervical Flexion Test
Subjective Sleep Quality |
pre and 7 weeks post interventions |
|
Target Sample Size
Modification(s)
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="31" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2019 |
| Date of Study Completion (India) |
15/04/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="1"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
polysomnographic study of sleep disruptions in individuals with chronic neck pain. Journal of Sleep Research. 2022 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1. This
study shall provide an understanding of subjective sleep quality and
fatigue in chronic neck pain patients (study 1).
2. This
Study will examine the prevalence of sleep disturbance and its correlation with
pain ,fatigue and other measures in CNP patients(Study1_
3.
This study will illustrate objective quality
of sleep, UT fatigue and nocturnal UT muscle activity in CNP patients Study
(II).
4.
The main clinical contribution of this study
is to help patients with chronic neck pain to reduce their pain and improve
their sleep quality and QOL Study (II).
5.
The present study will also elucidate the effect
of various physiotherapy interventions to ameliorate pain in CNP patients with
sleep disturbances Study (II).
6.
If came out with positive findings, the
present study protocol may be used for improving sleep, fatigue as
well as reducing the pain and improve the quality of life in CNP
patients Study(II).
7.
The study will also further strengthen the
evidence on the role of non-invasive and non-pharmacological interventions to
improve sleep and reduce the pain in CNP patients Study (II).
8.
As a whole, this study will be one of the
very few adequately sampled randomized control trials investigating the effect
of physiotherapy interventions, which could targets the underlying mechanism of
sleep disturbance, fatigue and pain in CNP patients. |