Effect of Allium Cepa in the Management of Shoulder Pain Post Stroke

Stroke Clinical Trial

Official title:

Effect of Allium Cepa (Onion)in the Management of Shoulder Pain Post Stroke : A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03468049
• Other study ID #: HMohammed
• Status: Completed
• Phase: Early Phase 1
• Start date: June 11, 2018
• Est. completion date: June 14, 2019

Study information

• Verified date: November 2019
• Source: Bayero University Kano, Nigeria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 14, 2019
• Est. primary completion date: June 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Pain
• Stroke

Intervention

Biological:
• Topical App. of Allium Cepa Extract
Topical Application of Allium Cepa Extract (oil)
• Phonophoresis of Allium Cepa Extract
Phonophoresis of Allium Cepa Extract (oil)
• Raw Mashed Allium Cepa Application
Raw Allium Cepa (onion bulb) Mashed

Other:
• Standard Physiotherapy Group (SPG)
This will consist of Massage and therapeutic exercise for the management of shoulder pain post stroke

Locations

Country	Name	City	State
Nigeria	Amina Kano Teaching Hospital	Kano

Sponsors (2)

Lead Sponsor	Collaborator
Bayero University Kano, Nigeria	Physiotherapy Associates

Country where clinical trial is conducted

Nigeria, 

References & Publications (8)

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

Donnan GA, Fisher M, Macleod M, Davis SM. Stroke. Lancet. 2008 May 10;371(9624):1612-23. doi: 10.1016/S0140-6736(08)60694-7. Review. — View Citation

Hoang CL, Salle JY, Mandigout S, Hamonet J, Macian-Montoro F, Daviet JC. Physical factors associated with fatigue after stroke: an exploratory study. Top Stroke Rehabil. 2012 Sep-Oct;19(5):369-76. doi: 10.1310/tsr1905-369. — View Citation

Jackson D, Turner-Stokes L, Williams H, Das-Gupta R. Use of an integrated care pathway: a third round audit of the management of shoulder pain in neurological conditions. J Rehabil Med. 2003 Nov;35(6):265-70. — View Citation

Lundström E, Smits A, Terént A, Borg J. Risk factors for stroke-related pain 1 year after first-ever stroke. Eur J Neurol. 2009 Feb;16(2):188-93. doi: 10.1111/j.1468-1331.2008.02378.x. Epub 2008 Dec 9. — View 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. — View 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. — View Citation

Walsh K. Management of shoulder pain in patients with stroke. Postgrad Med J. 2001 Oct;77(912):645-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale	This was used to assess pain intensity of participants in this study. It is usually 10cm (100mm [0-4mm no pain, 5-44mm mild pain, 45-74mm moderate pain and 75-100mm severe pain] in length with two verbal descriptors for the two symptoms extremes. The score ranges from 0-10, with 0 being no pain and 10 pain as bad as possible or worst imaginable pain. Verbal descriptors and numbers at the intermediate points are not recommended in order to avoid clustering of scores around a preferred numeric value.	1 minute
Primary	Fugl Meyer Assessment Scale (upper extremity)	This was used to assess the recovery of shoulder joint functional outcome. The items are scored on a 3 points ordinal scale [0 (cannot perform), 1(performs partially) and 2 (performs fully)] with maximum score of 226 points. It assesses five domains which include motor function (for upper extremity = 66 and lower extremity = 34), sensory function = 24, balance = 14, joint range of motion = 44 and joint pain = 44. Interpretation of fugyl meyer assessment is as follows 0-35 = very severe, 36-55 = severe, 56-79 = moderate and >79 mild for motor assessment.	15 minutes
Secondary	Stroke Impact Scale	this will be use to assess participant quality of life. It is a 59 items measure divided into eight domains namely; strength (4 items), hand function (5 items), ADL/IADL (10 items), mobility (9 items), communication (7 items), emotion (9 items), memory and thinking (7 items) and participation/role function (8 items). Each item is rated in a 5-points likert scale in terms of the difficulty the patient has experienced in completing the item. Summative score are generated for each domain, score range from 0-100. Stroke Impact Scale has an extra questions on stroke recovery that ask the client rate of recovery on a scale of 0-100, with 0 being no recovery and 100 full recovery	15 minutes