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

NCT03468049 | Completed Early Phase 1 DMC

• 1 other identifier: HMohammed
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Stroke Impact Scale

  15 minutes

Study Arms (4)

Topical App. of Allium Cepa Extract

EXPERIMENTAL

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

Biological: Topical App. of Allium Cepa Extract; Other: Standard Physiotherapy Group (SPG)

Phonophoresis of Allium Cepa extract

EXPERIMENTAL

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

Biological: Phonophoresis of Allium Cepa Extract; Other: Standard Physiotherapy Group (SPG)

Raw mashed Allium Cepa Application

EXPERIMENTAL

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

Biological: Raw Mashed Allium Cepa Application; Other: Standard Physiotherapy Group (SPG)

Standard physiotherapy group (SPG)

ACTIVE COMPARATOR

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

Other: Standard Physiotherapy Group (SPG)

Interventions

Topical App. of Allium Cepa Extract BIOLOGICAL

Topical Application of Allium Cepa Extract (oil)

Topical App. of Allium Cepa Extract

Phonophoresis of Allium Cepa Extract BIOLOGICAL

Phonophoresis of Allium Cepa Extract (oil)

Phonophoresis of Allium Cepa extract

Raw Mashed Allium Cepa Application BIOLOGICAL

Raw Allium Cepa (onion bulb) Mashed

Raw mashed Allium Cepa Application

Standard Physiotherapy Group (SPG) OTHER

This will consist of Massage and therapeutic exercise for the management of shoulder pain post stroke

Phonophoresis of Allium Cepa extract; Raw mashed Allium Cepa Application; Standard physiotherapy group (SPG); Topical App. of Allium Cepa Extract

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayero University Kano, Nigeria: lead
• Physiotherapy Associates: collaborator

Study Sites (1)

Amina Kano Teaching Hospital

Kano, +234, Nigeria

Location

Related 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

  BACKGROUND

• 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.

  PMID: 14664316 BACKGROUND

• 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.

  PMID: 18468545 RESULT

• 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.

  PMID: 22982823 RESULT

• 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.

  PMID: 19138338 RESULT

• 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.

  PMID: 22910531 RESULT

• 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.

  PMID: 23559265 RESULT

• 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.

  PMID: 11571371 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Isa U Lawal, BSc MSc PhD

  Bayero University Kano

  STUDY DIRECTOR

• Hauwa H Mohammed, BMR,MSc

  Bayero University Kano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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

Study Record Dates

• First Submitted: March 11, 2018
• First Posted: March 16, 2018
• Study Start: June 11, 2018
• Primary Completion: June 14, 2019
• Study Completion: June 14, 2019
• Last Updated: November 6, 2019

Record last verified: 2019-11

Locations

NG (1)