Clinical trial NCT03468049: Effect of Allium Cepa in the Management of Shoulder Pain Post Stroke
Official title: Effect of Allium Cepa (Onion)in the Management of Shoulder Pain Post Stroke : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Stroke
Lead sponsor: Bayero University Kano, Nigeria
Sponsor class: OTHER
Collaborators: name: Physiotherapy Associates
First posted: 2018-03-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participant will be randomly allocated into 4 groups Topical Application of Allum Cepa Extract, Phonophoresis of Allium Cepa Etract, Raw Mashed Allium Cepa Application and Standard Physiotherapy group ) the first 3 groups will be recieving standard physiotherapy management of shoulder pain post stroke just like those in the standard physiotherapy group in addition to specific treatment assigned to each of the groups
Primary purpose: TREATMENT

Brief summary: One of the disabling consequences of stroke is hemipleic shoulder pain. Hemiplegic shoulder pain could be most important hinderance to upper extremity function after stroke . Evidence for rehabilitation approaches for shuolder pain suggested diverse approaches with strong need for further studies. This study planned to investigate the effect of Allium Cepa in the management of shoulder pain post stroke using four arms of the studying with three intervention groups and control group All participants who met study inclusion criteria and gave their consent shall be assessed at baseline for impairment (Fugl Meyer Assessment), activity limitation (Brief Pain Inventory) and participation restrictions (Stroke Impact Scale)

Detailed description: Globally, stroke is the second most common cause of death and a major cause of disability. One of the disabling consequences of stroke is hemipleic shoulder pain which on its own could result in disability. Physical therapy is an integral part of post stroke rehabilitation, and plays an important role in the prevention and treatment of hemiplegic shoulder pain. Generally, patients with pain will most likely experience greater cognitive impairment and functional decline, lower quality of life, fatigue, depression and often poorly cooperate in rehabilitation. It was reported from a study that the ideal management of hemiplegic shoulder pain is to prevent it from happening in the first place, once the patient developed pain, resultant anxiety and over protection will follow. Hemiplegic shoulder pain can also interfere with arm recovery, reduce activity of daily living and markedly hinder rehabilitation.Similarly, a study have reported shoulder pain to cause considerable distress, discomfort, interference with rehabilitation, delay in discharge and that it is generally poorly managed. A recently updated Evidence-Based Review of Stroke Rehabilitation (EBRSR) on painful hemiplegic shoulder summarised 19 key points about painful hemiplegic shoulder; while all the 19 points are essential, the need for these study is closely related by some of these points these include Aggressive range of motion exercises (i.e. pullies) results in a markedly increased incidence of painful shoulder; a gentler range of motion program is preferred. Adding ultrasound treatments does not appear to improve shoulder range of motion, Treatment with surface neuromuscular electrical stimulation (NMES) early (\< 6 months) post-stroke may reduce shoulder subluxation but not pain associated with shoulder hemiplegia. Surface NMES delivered after 6 months provides no additional benefits over conventional therapy on shoulder subluxation. Intramuscular NMES however, has been found to reduce shoulder pain up to 12 months post-therapy, Strapping/taping the hemiplegic shoulder does not appear to improve upper limb function, but may reduce pain, Further research is needed to determine the benefits of aromatherapy in combination with acupressure regarding its effects on reducing pain caused by shoulder hemiplegia and Massage therapy may reduce hemiplegic shoulder pain, anxiety, and other physiological functions (i.e. blood pressure, and heart rate) however, more research is still warranted. This study will therefore investigat the effect of Allium cepa(onion) in the management of shoulder pain post stoke.

Eligibility criteria: Inclusion Criteria:Participants who had hemiplegic shoulder pain after stroke with age range of 18 years and above who are able to express pain level and communicate in general

Exclusion Criteria:

1. Stroke survivors with significant cognitive impairment (\< 18 on a mini mental scale) and language impairment that would prevent the patient from answering questions reliably.
2. Stroke survivors who had sustained shoulder pain caused by condition other than hemiplegia such as fracture, vertebral origin, dislocation, inflammatory arthritis (rheumatoid and gout) and fibromyalgia.
3. Participants who exhibit allergy to Allium Cepa (skin sensitivity or finds the odor offensive).
4. Participants who do not agree to use Allium Cepa

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 1 minute
measure: Fugl Meyer Assessment Scale (upper extremity)
timeFrame: 15 minutes
Secondary outcomes:
measure: Stroke Impact Scale
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Kano
country: Nigeria
facility: Amina Kano Teaching Hospital
Study officials:
affiliation: Bayero University Kano
name: Isa U Lawal, BSc MSc PhD
role: STUDY_DIRECTOR
affiliation: Bayero University Kano
name: Hauwa H Mohammed, BMR,MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cotoi, A., Viana, R., Wilson, R., Chae, J., Miller, T., Foley, N., & Teasell, R.Painful hemiplegic shoulder. Evidence-based review of stroke rehabilitation, 1-56.2016
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citation: Naess H, Lunde L, Brogger J. The effects of fatigue, pain, and depression on quality of life in ischemic stroke patients: the Bergen Stroke Study. Vasc Health Risk Manag. 2012;8:407-13. doi: 10.2147/VHRM.S32780. Epub 2012 Jun 27.
citation: O'Donnell MJ, Diener HC, Sacco RL, Panju AA, Vinisko R, Yusuf S; PRoFESS Investigators. Chronic pain syndromes after ischemic stroke: PRoFESS trial. Stroke. 2013 May;44(5):1238-43. doi: 10.1161/STROKEAHA.111.671008. Epub 2013 Apr 4.
citation: Walsh K. Management of shoulder pain in patients with stroke. Postgrad Med J. 2001 Oct;77(912):645-9. doi: 10.1136/pmj.77.912.645.