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

Primary Purpose

Stroke

Status
Completed
Phase
Early Phase 1
Locations
Nigeria
Study Type
Interventional
Intervention
Topical App. of Allium Cepa Extract
Phonophoresis of Allium Cepa Extract
Raw Mashed Allium Cepa Application
Standard Physiotherapy Group (SPG)
Sponsored by
Bayero University Kano, Nigeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Amina Kano Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Topical App. of Allium Cepa Extract

Phonophoresis of Allium Cepa extract

Raw mashed Allium Cepa Application

Standard physiotherapy group (SPG)

Arm Description

Intervention: 5mg of Allium Cepa Extract (Allium Cepa oil) will be applied on the shoulder joint of the participant, followed by kneading massage until the Allium Cepa oil deeply penetrate into the shoulder joint in addition to standard physiotherapy management of shoulder pain post stroke. Three times in a week for four weeks

Intervention: 5mg of Allium Cepa extract (Allium Cepa oil) would be applied on the shoulder joint of the participant, followed by phonophoresis using ultrasound set at at treatment parameter of pulse mode (50%), 1mHz transducer frequency and stroking technique of 1.5w/cm square for 5mins to allow deeper penetration of the Allium Cepa oilinto the joint in addition to standard physiotherapy management of shoulder pain post stroke.Three times in a week for four weeks

Intervention: 5g or a small size Raw Allium Cepa (onion)bulb will be cut into pieces and then mashed inside pestle and mortar, thereafter the Raw mashed Allium Cepa will then be applied on the surface of the shoulder joint of the participant and then secured with a gauze bandage for 2 hours to allow deeper penetrationin addition to standard physiotherapy management of shoulder pain post stroke. Three times in a week for four weeks

Participant in this group will be receiving standard physiotherapy management of shoulder pain post stroke. The standard physiotherapy management will divided into two forms of activities, the first approach is soft tissue manipulation using common massage medium in particular powder would be used in this study. The second approach is the use of therapeutic exercises and this therapeutic exercises will be categorized into three (basic level, intermediate level and advance level of shoulder joint exercises) depending on the stage of recovery of the participants. Three times in a week for four weeks

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
March 11, 2018
Last Updated
November 4, 2019
Sponsor
Bayero University Kano, Nigeria
Collaborators
Physiotherapy Associates
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1. Study Identification

Unique Protocol Identification Number
NCT03468049
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
June 14, 2019 (Actual)
Study Completion Date
June 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bayero University Kano, Nigeria
Collaborators
Physiotherapy Associates

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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
Masking
Outcomes Assessor
Masking Description
the outcome assessor will be blinded from knowing the nature of treatment that participants will be recieving either in the intervention groups or control group
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topical App. of Allium Cepa Extract
Arm Type
Experimental
Arm Description
Intervention: 5mg of Allium Cepa Extract (Allium Cepa oil) will be applied on the shoulder joint of the participant, followed by kneading massage until the Allium Cepa oil deeply penetrate into the shoulder joint in addition to standard physiotherapy management of shoulder pain post stroke. Three times in a week for four weeks
Arm Title
Phonophoresis of Allium Cepa extract
Arm Type
Experimental
Arm Description
Intervention: 5mg of Allium Cepa extract (Allium Cepa oil) would be applied on the shoulder joint of the participant, followed by phonophoresis using ultrasound set at at treatment parameter of pulse mode (50%), 1mHz transducer frequency and stroking technique of 1.5w/cm square for 5mins to allow deeper penetration of the Allium Cepa oilinto the joint in addition to standard physiotherapy management of shoulder pain post stroke.Three times in a week for four weeks
Arm Title
Raw mashed Allium Cepa Application
Arm Type
Experimental
Arm Description
Intervention: 5g or a small size Raw Allium Cepa (onion)bulb will be cut into pieces and then mashed inside pestle and mortar, thereafter the Raw mashed Allium Cepa will then be applied on the surface of the shoulder joint of the participant and then secured with a gauze bandage for 2 hours to allow deeper penetrationin addition to standard physiotherapy management of shoulder pain post stroke. Three times in a week for four weeks
Arm Title
Standard physiotherapy group (SPG)
Arm Type
Active Comparator
Arm Description
Participant in this group will be receiving standard physiotherapy management of shoulder pain post stroke. The standard physiotherapy management will divided into two forms of activities, the first approach is soft tissue manipulation using common massage medium in particular powder would be used in this study. The second approach is the use of therapeutic exercises and this therapeutic exercises will be categorized into three (basic level, intermediate level and advance level of shoulder joint exercises) depending on the stage of recovery of the participants. Three times in a week for four weeks
Intervention Type
Biological
Intervention Name(s)
Topical App. of Allium Cepa Extract
Intervention Description
Topical Application of Allium Cepa Extract (oil)
Intervention Type
Biological
Intervention Name(s)
Phonophoresis of Allium Cepa Extract
Intervention Description
Phonophoresis of Allium Cepa Extract (oil)
Intervention Type
Biological
Intervention Name(s)
Raw Mashed Allium Cepa Application
Intervention Description
Raw Allium Cepa (onion bulb) Mashed
Intervention Type
Other
Intervention Name(s)
Standard Physiotherapy Group (SPG)
Intervention Description
This will consist of Massage and therapeutic exercise for the management of shoulder pain post stroke
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
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.
Time Frame
1 minute
Title
Fugl Meyer Assessment Scale (upper extremity)
Description
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.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Stroke Impact Scale
Description
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
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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: Stroke survivors with significant cognitive impairment (< 18 on a mini mental scale) and language impairment that would prevent the patient from answering questions reliably. 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. Participants who exhibit allergy to Allium Cepa (skin sensitivity or finds the odor offensive). Participants who do not agree to use Allium Cepa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isa U Lawal, BSc MSc PhD
Organizational Affiliation
Bayero University Kano
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hauwa H Mohammed, BMR,MSc
Organizational Affiliation
Bayero University Kano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amina Kano Teaching Hospital
City
Kano
ZIP/Postal Code
+234
Country
Nigeria

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Organizing seminar and workshop for patients and relatives, Engaging in clinical meetings and publishing the study findinds
Citations:
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
Results Reference
background
PubMed Identifier
14664316
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. doi: 10.1080/16501970310012446.
Results Reference
background
PubMed Identifier
18468545
Citation
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.
Results Reference
result
PubMed Identifier
22982823
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.
Results Reference
result
PubMed Identifier
19138338
Citation
Lundstrom E, Smits A, Terent 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.
Results Reference
result
PubMed Identifier
22910531
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.
Results Reference
result
PubMed Identifier
23559265
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.
Results Reference
result
PubMed Identifier
11571371
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.
Results Reference
result

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

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