Studies on understanding the relationship between chronic neck pain and sleep disturbance: A physiotherapy intervention.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Jamia Millia Islamia
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 1 Objective (PSG) sleep parameters.
Study Overview
Brief Summary
1. Thisstudy shall provide an understanding of subjective sleep quality andfatigue in chronic neck pain patients (study 1).
2. ThisStudy will examine the prevalence of sleep disturbance and its correlation withpain ,fatigue and other measures in CNP patients(Study1_
3. This study will illustrate objective qualityof sleep, UT fatigue and nocturnal UT muscle activity in CNP patients Study(II).
4. The main clinical contribution of this studyis to help patients with chronic neck pain to reduce their pain and improvetheir sleep quality and QOL Study (II).
5. The present study will also elucidate the effectof various physiotherapy interventions to ameliorate pain in CNP patients withsleep disturbances Study (II).
6. If came out with positive findings, thepresent study protocol may be used for improving sleep, fatigue aswell as reducing the pain and improve the quality of life in CNPpatients Study(II).
7. The study will also further strengthen theevidence on the role of non-invasive and non-pharmacological interventions toimprove sleep and reduce the pain in CNP patients Study (II).
8. As a whole, this study will be one of thevery few adequately sampled randomized control trials investigating the effectof physiotherapy interventions, which could targets the underlying mechanism ofsleep disturbance, fatigue and pain in CNP patients.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, fixed
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 21.00 Year(s) to 50.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
1 Objective (PSG) sleep parameters.
Time Frame: Pre intervention (day 0) and post intervention (after 7 weeks (30 sessions)
2 Myoelectric Manifestations/fatigue parameters of upper trapezius (Mean, median power frequency and RMS).
Time Frame: Pre intervention (day 0) and post intervention (after 7 weeks (30 sessions)
4. Pain Intensity
Time Frame: Pre intervention (day 0) and post intervention (after 7 weeks (30 sessions)
3. Nocturnal Activity of upper trapezius during Wake, NREM and REM sleep.
Time Frame: Pre intervention (day 0) and post intervention (after 7 weeks (30 sessions)
Secondary Outcomes
- disability(Craniocervical Flexion Test)